Frequencies for enfrep20151014 dataset : by Jean Roth , jroth@nber.org , 18 Dec 2015 Frequencies for producttype variable in enfrep20151014 dataset : Product | Type | Freq. Percent Cum. ------------+----------------------------------- Biologics | 9 24.32 24.32 Devices | 20 54.05 78.38 Drugs | 3 8.11 86.49 Food | 5 13.51 100.00 ------------+----------------------------------- Total | 37 100.00 Frequencies for eventid variable in enfrep20151014 dataset : Event ID | Freq. Percent Cum. ------------+----------------------------------- 71763 | 1 2.70 2.70 71899 | 1 2.70 5.41 71979 | 1 2.70 8.11 72002 | 2 5.41 13.51 72068 | 1 2.70 16.22 72090 | 1 2.70 18.92 72091 | 3 8.11 27.03 72107 | 1 2.70 29.73 72113 | 1 2.70 32.43 72121 | 1 2.70 35.14 72131 | 1 2.70 37.84 72137 | 1 2.70 40.54 72146 | 1 2.70 43.24 72151 | 1 2.70 45.95 72152 | 1 2.70 48.65 72170 | 1 2.70 51.35 72174 | 1 2.70 54.05 72175 | 1 2.70 56.76 72176 | 2 5.41 62.16 72188 | 1 2.70 64.86 72189 | 1 2.70 67.57 72207 | 2 5.41 72.97 72212 | 1 2.70 75.68 72219 | 1 2.70 78.38 72221 | 1 2.70 81.08 72235 | 1 2.70 83.78 72238 | 1 2.70 86.49 72242 | 1 2.70 89.19 72245 | 1 2.70 91.89 72271 | 1 2.70 94.59 72324 | 1 2.70 97.30 72343 | 1 2.70 100.00 ------------+----------------------------------- Total | 37 100.00 Frequencies for status variable in enfrep20151014 dataset : Status | Freq. Percent Cum. ------------+----------------------------------- Ongoing | 27 72.97 72.97 Terminated | 10 27.03 100.00 ------------+----------------------------------- Total | 37 100.00 Frequencies for recallingfirm variable in enfrep20151014 dataset : Recalling Firm | Freq. Percent Cum. ----------------------------------------+----------------------------------- American Red Cross Blood Services | 3 8.11 8.11 Beckman Coulter Inc. | 3 8.11 16.22 Caribou Coffee Company Inc. | 2 5.41 21.62 Central Pennsylvania Blood Bank | 1 2.70 24.32 Community Blood Center of Carolinas | 1 2.70 27.03 CooperSurgical, Inc. | 1 2.70 29.73 DePuy Orthopaedics, Inc. | 1 2.70 32.43 Diabetes Corporation of America dba D.. | 1 2.70 35.14 Elekta, Inc. | 1 2.70 37.84 GE Healthcare | 1 2.70 40.54 General Mills, Inc | 1 2.70 43.24 HCSC-Blood Center | 1 2.70 45.95 Integra LifeSciences Corp. | 1 2.70 48.65 Medtronic Inc. Cardiac Rhythm Disease.. | 1 2.70 51.35 Merck Sharp & Dohme, Wilson Facility | 1 2.70 54.05 NewStar Fresh Foods, LLC | 1 2.70 56.76 Noven Pharmaceuticals, Inc. | 1 2.70 59.46 Olympus Corporation of the Americas | 1 2.70 62.16 OneBlood, Inc. | 1 2.70 64.86 Ortho Solutions Inc | 1 2.70 67.57 Reily Foods Co. | 1 2.70 70.27 Siemens Medical Solutions USA, Inc | 5 13.51 83.78 Stryker Craniomaxillofacial Division | 1 2.70 86.49 Synthes (USA) Products LLC | 1 2.70 89.19 The American National Red Cross - Sou.. | 1 2.70 91.89 The Blood Center | 1 2.70 94.59 Toshiba American Medical Systems Inc | 1 2.70 97.30 Zimmer, Inc. | 1 2.70 100.00 ----------------------------------------+----------------------------------- Total | 37 100.00 Frequencies for city variable in enfrep20151014 dataset : City | Freq. Percent Cum. ----------------+----------------------------------- Atlanta | 1 2.70 2.70 Barrington | 1 2.70 5.41 Bethlehem | 1 2.70 8.11 Brea | 3 8.11 16.22 Brooklyn Center | 2 5.41 21.62 Center Valley | 1 2.70 24.32 Charlotte | 1 2.70 27.03 Douglasville | 1 2.70 29.73 Farmington | 1 2.70 32.43 Franklin | 1 2.70 35.14 Hummelstown | 1 2.70 37.84 Mahwah | 1 2.70 40.54 Malvern | 5 13.51 54.05 Miami | 1 2.70 56.76 Minneapolis | 1 2.70 59.46 New Orleans | 2 5.41 64.86 Omaha | 2 5.41 70.27 Plainsboro | 1 2.70 72.97 Portage | 1 2.70 75.68 Saint Paul | 1 2.70 78.38 Salinas | 1 2.70 81.08 St Petersburg | 1 2.70 83.78 Trumbull | 1 2.70 86.49 Tustin | 1 2.70 89.19 Warsaw | 2 5.41 94.59 West Chester | 1 2.70 97.30 Wilson | 1 2.70 100.00 ----------------+----------------------------------- Total | 37 100.00 Frequencies for state variable in enfrep20151014 dataset : State | Freq. Percent Cum. ------------+----------------------------------- CA | 5 13.51 13.51 CT | 2 5.41 18.92 FL | 2 5.41 24.32 GA | 2 5.41 29.73 IL | 1 2.70 32.43 IN | 2 5.41 37.84 LA | 2 5.41 43.24 MI | 1 2.70 45.95 MN | 4 10.81 56.76 NC | 2 5.41 62.16 NE | 2 5.41 67.57 NJ | 2 5.41 72.97 PA | 9 24.32 97.30 TN | 1 2.70 100.00 ------------+----------------------------------- Total | 37 100.00 Frequencies for country variable in enfrep20151014 dataset : Country | Freq. Percent Cum. ------------+----------------------------------- US | 37 100.00 100.00 ------------+----------------------------------- Total | 37 100.00 Frequencies for voluntarymandated variable in enfrep20151014 dataset : Voluntary/Mandated | Freq. Percent Cum. --------------------------+----------------------------------- Voluntary: Firm Initiated | 37 100.00 100.00 --------------------------+----------------------------------- Total | 37 100.00 Frequencies for initialfirmnotificationofconsign variable in enfrep20151014 dataset : Initial Firm Notification of Consignee | or Public | Freq. Percent Cum. ----------------------------------------+----------------------------------- E-Mail | 3 8.11 8.11 FAX | 3 8.11 16.22 Letter | 22 59.46 75.68 Other | 2 5.41 81.08 Telephone | 4 10.81 91.89 Two or more of the following: Email, .. | 3 8.11 100.00 ----------------------------------------+----------------------------------- Total | 37 100.00 Frequencies for distributionpattern variable in enfrep20151014 dataset : Distribution Pattern | Freq. Percent Cum. ----------------------------------------+----------------------------------- California | 2 5.41 5.41 Distributed in NC, AL, KS, TX, UT, CA.. | 1 2.70 8.11 Florida | 1 2.70 10.81 GA, MD, KY, AL, NC, VA, TX, TN, NJ, F.. | 1 2.70 13.51 KY, MS and OH. | 1 2.70 16.22 KY, OH, TN | 1 2.70 18.92 Louisiana | 1 2.70 21.62 Minnesota; California | 2 5.41 27.03 NY,TX, OK, OR, LA, KS, IN. MO, HI, CA.. | 1 2.70 29.73 Nationally | 1 2.70 32.43 Nationwide Distribution | 1 2.70 35.14 Nationwide Distribution. | 3 8.11 43.24 North Carolina | 1 2.70 45.95 Pennsylvania | 2 5.41 51.35 US (nationwide) and Canada. | 1 2.70 54.05 US Distribution to states of: CA, CO,.. | 1 2.70 56.76 US Distribution to states of: MA, MO,.. | 1 2.70 59.46 US Distribution to the state of Nevada. | 1 2.70 62.16 US Distribution to the states of : AL.. | 1 2.70 64.86 US Nationwide | 1 2.70 67.57 US nationwide distribution. | 1 2.70 70.27 US: AL, CO, GA, IL IN, IA, KS, MI, M.. | 2 5.41 75.68 Worldwide Distribution - US (nationwi.. | 1 2.70 78.38 Worldwide Distribution - US Distribut.. | 1 2.70 81.08 Worldwide Distribution - US Nationwid.. | 2 5.41 86.49 Worldwide Distribution - US including.. | 1 2.70 89.19 Worldwide Distribution -- US, includi.. | 1 2.70 91.89 Worldwide Distribution: US (nationwid.. | 1 2.70 94.59 Worldwide distribution -- US, Canada,.. | 1 2.70 97.30 nationwide | 1 2.70 100.00 ----------------------------------------+----------------------------------- Total | 37 100.00 Frequencies for recallnumber variable in enfrep20151014 dataset : Recall | Number | Freq. Percent Cum. ------------+----------------------------------- B-0001-16 | 1 2.70 2.70 B-0002-16 | 1 2.70 5.41 B-0003-16 | 1 2.70 8.11 B-0004-16 | 1 2.70 10.81 B-0008-16 | 1 2.70 13.51 B-0009-16 | 1 2.70 16.22 B-0010-16 | 1 2.70 18.92 B-0011-16 | 1 2.70 21.62 B-0013-16 | 1 2.70 24.32 D-0006-2016 | 1 2.70 27.03 D-0007-2016 | 1 2.70 29.73 D-0008-2016 | 1 2.70 32.43 F-0001-2016 | 1 2.70 35.14 F-0003-2016 | 1 2.70 37.84 F-0004-2016 | 1 2.70 40.54 F-0005-2016 | 1 2.70 43.24 F-0006-2016 | 1 2.70 45.95 Z-0005-2016 | 1 2.70 48.65 Z-0019-2016 | 1 2.70 51.35 Z-0020-2016 | 1 2.70 54.05 Z-0021-2016 | 1 2.70 56.76 Z-0022-2016 | 1 2.70 59.46 Z-0023-2016 | 1 2.70 62.16 Z-0024-2016 | 1 2.70 64.86 Z-0025-2016 | 1 2.70 67.57 Z-0026-2016 | 1 2.70 70.27 Z-0027-2016 | 1 2.70 72.97 Z-0105-2016 | 1 2.70 75.68 Z-0106-2016 | 1 2.70 78.38 Z-0107-2016 | 1 2.70 81.08 Z-0108-2016 | 1 2.70 83.78 Z-0109-2016 | 1 2.70 86.49 Z-0110-2016 | 1 2.70 89.19 Z-0111-2016 | 1 2.70 91.89 Z-0112-2016 | 1 2.70 94.59 Z-0113-2016 | 1 2.70 97.30 Z-0114-2016 | 1 2.70 100.00 ------------+----------------------------------- Total | 37 100.00 Frequencies for classification variable in enfrep20151014 dataset : Classificat | ion | Freq. Percent Cum. ------------+----------------------------------- Class II | 28 75.68 75.68 Class III | 9 24.32 100.00 ------------+----------------------------------- Total | 37 100.00 Frequencies for productdescription variable in enfrep20151014 dataset : Product Description | Freq. Percent Cum. ----------------------------------------+----------------------------------- Specialist 2 Intramedullary (SP2 IM).. | 1 2.70 2.70 Access Free T3 Reagent Kit, P/N A1342.. | 1 2.70 5.41 Blood and Blood Products for Reproces.. | 3 8.11 13.51 Blue Plate(R) LIGHT MAYONNAISE, 18 Fl.. | 1 2.70 16.22 Caribou Almond Biscotti, Net Wt. 1.4 .. | 1 2.70 18.92 Caribou Chocolate Chip Toffee Pecan B.. | 1 2.70 21.62 Cascadian Farm Organic Cut Green Bean.. | 1 2.70 24.32 Celesteion PCA-9000A/2 PET/CT System | 1 2.70 27.03 Centricity PACS IW by GE Healthcare D.. | 1 2.70 29.73 CooperSurgical LEEP REDIKIT-Used as a.. | 1 2.70 32.43 Daytrana (methylphenidate transdermal.. | 1 2.70 35.14 Disposable Paper Filter for Steriliza.. | 1 2.70 37.84 MAJ-1606 Instrument Channel Adaptor; .. | 1 2.70 40.54 MICroSTREP plus 1 Panel, Part No. B10.. | 1 2.70 43.24 MICroSTREP plus 2 Panel, Part No. B10.. | 1 2.70 45.95 Medtronic Medical Device Identificati.. | 1 2.70 48.65 Monaco Radiation Treatment Planning S.. | 1 2.70 51.35 Ortho OS Solutions UltOS 3.5mm lockin.. | 1 2.70 54.05 Platelets Leukocytes Reduced | 1 2.70 56.76 Platelets Pheresis Leukocytes Reduced | 2 5.41 62.16 Red Blood Cells | 1 2.70 64.86 Red Blood Cells Leukocytes Reduced | 2 5.41 70.27 SOMATOM Definition AS, intended to pr.. | 1 2.70 72.97 SOMATOM Definition Edge; intended to .. | 1 2.70 75.68 SOMATOM Definition Flash; intended to.. | 1 2.70 78.38 SOMATOM Force; computed tomography x-.. | 1 2.70 81.08 Sermorelin 6mg/6mL Lyophilized Powder.. | 1 2.70 83.78 Syngo RT Oncologist, an optional acce.. | 1 2.70 86.49 Synthes Periarticular Insertion Handl.. | 1 2.70 89.19 Universal Compact Head Ring Adapter P.. | 1 2.70 91.89 Vytorin (ezetimibe and simvastatin) t.. | 1 2.70 94.59 Zimmer Universal Locking System, Tita.. | 1 2.70 97.30 organic girl - good clean greens baby.. | 1 2.70 100.00 ----------------------------------------+----------------------------------- Total | 37 100.00 Frequencies for codeinfo variable in enfrep20151014 dataset : Code Info | Freq. Percent Cum. ----------------------------------------+----------------------------------- 2016-01-27 2016-02-27 2016-03-26 .. | 1 2.70 2.70 2016-01-30 2016-03-23 | 1 2.70 5.41 By 29JUN2017 | 1 2.70 8.11 Cat. No. UCHRAP; Serial No.s 900, 901.. | 1 2.70 10.81 GE Centricity PACS-IW versions 3.5.0 .. | 1 2.70 13.51 Item No. 00-4836-080-00; Lot 56555128 | 1 2.70 16.22 LOT 187889 | 1 2.70 18.92 Lot #: 101614, Exp 4/30/2015 | 1 2.70 21.62 Lot #: 75983, Expiry: 11/15 | 1 2.70 24.32 Lot Code 1507280401 Best by 07/27/2016 | 1 2.70 27.03 Lot number: L013425, Exp. 11/2016 | 1 2.70 29.73 Lot: 431433 | 1 2.70 32.43 Model Number of device- 10568604, ser.. | 1 2.70 35.14 Model Number of device- 10742326 wit.. | 1 2.70 37.84 Model# 10430603 with Serial numbers .. | 1 2.70 40.54 Model#' 10590000 with Serial numbers .. | 1 2.70 43.24 Model#' 8098027 with Serial numbers .. | 1 2.70 45.95 Model: TSX-301 CI6A with system softw.. | 1 2.70 48.65 Models: Part number K10016901 is a p.. | 1 2.70 51.35 Part Number (Lot Number) infomration .. | 1 2.70 54.05 Part Number: 29-10911 Disposable Pa.. | 1 2.70 56.76 Part Numbers: 03.120.005 03.120.004 .. | 1 2.70 59.46 SKU 012963, All code dates, all use b.. | 1 2.70 62.16 SKU 012964, All code dates, all use b.. | 1 2.70 64.86 SP2 IM Rod 400mm Instruments (96-6120.. | 1 2.70 67.57 Software Version 5.10.00 | 1 2.70 70.27 W036815200043 (double); W036815200547.. | 1 2.70 72.97 W050911057258 | 1 2.70 75.68 W067115008967; W067115008969 | 1 2.70 78.38 W087615552323 | 1 2.70 81.08 W200315391527 | 1 2.70 83.78 W200915215388 | 2 5.41 89.19 W203314079761 | 1 2.70 91.89 W398515014161H (triple collection); W.. | 1 2.70 94.59 no codes on the cards | 1 2.70 97.30 use-by September 13, Lot code B030298.. | 1 2.70 100.00 ----------------------------------------+----------------------------------- Total | 37 100.00 Frequencies for codeinfocontinued variable in enfrep20151014 dataset : Code Info | (Continued) | Freq. Percent Cum. ------------+----------------------------------- . | 37 100.00 100.00 ------------+----------------------------------- Total | 37 100.00 Frequencies for productquantity variable in enfrep20151014 dataset : Product Quantity | Freq. Percent Cum. --------------------------------------+----------------------------------- | 1 2.70 2.70 1 | 1 2.70 5.41 1 unit | 6 16.22 21.62 113 total | 3 8.11 29.73 125,250 Patches | 1 2.70 32.43 129 vials | 1 2.70 35.14 1290 Cases (6 X 5 oz. per case) | 1 2.70 37.84 14 | 1 2.70 40.54 154 units | 1 2.70 43.24 16,648 units total (1874 units in US) | 1 2.70 45.95 172 | 1 2.70 48.65 18 units | 1 2.70 51.35 2 units | 1 2.70 54.05 21 | 1 2.70 56.76 305 units | 1 2.70 59.46 31060 | 1 2.70 62.16 438 units total (433 units in US) | 1 2.70 64.86 4689 cases | 1 2.70 67.57 5138 units total (4,360 units in US) | 1 2.70 70.27 6 units | 1 2.70 72.97 6166 cases of 24 | 1 2.70 75.68 659 Cases of 12 units | 1 2.70 78.38 7488 | 1 2.70 81.08 777 cards | 1 2.70 83.78 8303 cases of 24 | 1 2.70 86.49 875 units | 1 2.70 89.19 9 units | 2 5.41 94.59 915 packs | 1 2.70 97.30 921 systems are impacted. | 1 2.70 100.00 --------------------------------------+----------------------------------- Total | 37 100.00 Frequencies for reasonforrecall variable in enfrep20151014 dataset : Reason for Recall | Freq. Percent Cum. ----------------------------------------+----------------------------------- It was found that if specific operat.. | 1 2.70 2.70 Affected lots of Periarticular Aiming.. | 1 2.70 5.41 Beckman Coulter is recalling MICroSTR.. | 2 5.41 10.81 Beckman Coulter, Inc. is recalling Ac.. | 1 2.70 13.51 Biscotti Almond and Biscotti Chocolat.. | 2 5.41 18.92 Blood product, collected from a donor.. | 2 5.41 24.32 Blood product, which was stored at an.. | 1 2.70 27.03 Blood products, collected from a dono.. | 3 8.11 35.14 Blood products, collected on instrume.. | 1 2.70 37.84 Blood products, with a low platelet y.. | 1 2.70 40.54 DePuy Orthopaedics, Inc. is initiatin.. | 1 2.70 43.24 Defective Delivery System: Out of spe.. | 1 2.70 45.95 Detection of elevated level of Cadmiu.. | 1 2.70 48.65 Dose and MU are incorrect when CT ima.. | 1 2.70 51.35 General Mills is recalling a limited .. | 1 2.70 54.05 Images may be missing when a system p.. | 1 2.70 56.76 Integra identified that the UCHRAP co.. | 1 2.70 59.46 It was found through review of open C.. | 1 2.70 62.16 Kit Label incorrect :Labeled with Lid.. | 1 2.70 64.86 One lot of Blue Plate Light Mayonnais.. | 1 2.70 67.57 Ortho Solutions Inc is initiating a r.. | 1 2.70 70.27 Platelet products, which were labeled.. | 1 2.70 72.97 Presence of Foreign Tablet/Capsule: V.. | 1 2.70 75.68 Sermorelin 6mg/6mL Lyophilized Powder.. | 1 2.70 78.38 Software and firmware bugs | 1 2.70 81.08 Some Medical Device Identification Ca.. | 1 2.70 83.78 Stryker has become aware that the inh.. | 1 2.70 86.49 This update is intended to provide a .. | 1 2.70 89.19 small puncture marks in a sterile pac.. | 1 2.70 91.89 software bug issues for SW-Version VA.. | 3 8.11 100.00 ----------------------------------------+----------------------------------- Total | 37 100.00 Frequencies for recallinitiationdate variable in enfrep20151014 dataset : Recall | Initiation | Date | Freq. Percent Cum. ------------+----------------------------------- 06feb2015 | 1 2.70 2.70 08may2015 | 1 2.70 5.41 08jul2015 | 1 2.70 8.11 14jul2015 | 1 2.70 10.81 20jul2015 | 1 2.70 13.51 27jul2015 | 2 5.41 18.92 05aug2015 | 3 8.11 27.03 06aug2015 | 3 8.11 35.14 11aug2015 | 2 5.41 40.54 14aug2015 | 4 10.81 51.35 18aug2015 | 1 2.70 54.05 21aug2015 | 1 2.70 56.76 26aug2015 | 1 2.70 59.46 31aug2015 | 1 2.70 62.16 01sep2015 | 1 2.70 64.86 08sep2015 | 1 2.70 67.57 10sep2015 | 3 8.11 75.68 11sep2015 | 1 2.70 78.38 14sep2015 | 1 2.70 81.08 15sep2015 | 2 5.41 86.49 16sep2015 | 1 2.70 89.19 17sep2015 | 2 5.41 94.59 23sep2015 | 1 2.70 97.30 02oct2015 | 1 2.70 100.00 ------------+----------------------------------- Total | 37 100.00 Frequencies for recallinitiationdatestr variable in enfrep20151014 dataset : Recall | Initiation | Date | Freq. Percent Cum. ------------+----------------------------------- 02/06/2015 | 1 2.70 2.70 05/08/2015 | 1 2.70 5.41 07/08/2015 | 1 2.70 8.11 07/14/2015 | 1 2.70 10.81 07/20/2015 | 1 2.70 13.51 07/27/2015 | 2 5.41 18.92 08/05/2015 | 3 8.11 27.03 08/06/2015 | 3 8.11 35.14 08/11/2015 | 2 5.41 40.54 08/14/2015 | 4 10.81 51.35 08/18/2015 | 1 2.70 54.05 08/21/2015 | 1 2.70 56.76 08/26/2015 | 1 2.70 59.46 08/31/2015 | 1 2.70 62.16 09/01/2015 | 1 2.70 64.86 09/08/2015 | 1 2.70 67.57 09/10/2015 | 3 8.11 75.68 09/11/2015 | 1 2.70 78.38 09/14/2015 | 1 2.70 81.08 09/15/2015 | 2 5.41 86.49 09/16/2015 | 1 2.70 89.19 09/17/2015 | 2 5.41 94.59 09/23/2015 | 1 2.70 97.30 10/02/2015 | 1 2.70 100.00 ------------+----------------------------------- Total | 37 100.00 Frequencies for reportdate variable in enfrep20151014 dataset : Report Date | Freq. Percent Cum. ------------+----------------------------------- 14oct2015 | 37 100.00 100.00 ------------+----------------------------------- Total | 37 100.00 Frequencies for reportdatestr variable in enfrep20151014 dataset : Report Date | Freq. Percent Cum. ------------+----------------------------------- 10/14/2015 | 37 100.00 100.00 ------------+----------------------------------- Total | 37 100.00 by Jean Roth , jroth@nber.org , 18 Dec 2015