Frequencies for enfrep20180103 dataset : by Jean Roth , jroth@nber.org , 25 Jan 2018 Frequencies for producttype variable in enfrep20180103 dataset : Product | Type | Freq. Percent Cum. ------------+----------------------------------- Devices | 12 42.86 42.86 Drugs | 16 57.14 100.00 ------------+----------------------------------- Total | 28 100.00 Frequencies for eventid variable in enfrep20180103 dataset : Event ID | Freq. Percent Cum. ------------+----------------------------------- 77470 | 1 3.57 3.57 77611 | 1 3.57 7.14 77613 | 1 3.57 10.71 77789 | 1 3.57 14.29 78360 | 1 3.57 17.86 78505 | 1 3.57 21.43 78657 | 1 3.57 25.00 78658 | 1 3.57 28.57 78678 | 10 35.71 64.29 78686 | 4 14.29 78.57 78694 | 3 10.71 89.29 78728 | 1 3.57 92.86 78736 | 1 3.57 96.43 78773 | 1 3.57 100.00 ------------+----------------------------------- Total | 28 100.00 Frequencies for status variable in enfrep20180103 dataset : Status | Freq. Percent Cum. ------------+----------------------------------- Ongoing | 28 100.00 100.00 ------------+----------------------------------- Total | 28 100.00 Frequencies for recallingfirm variable in enfrep20180103 dataset : Recalling Firm | Freq. Percent Cum. ----------------------------------------+----------------------------------- Accuray Incorporated | 4 14.29 14.29 Bayer HealthCare Pharmaceuticals, Inc. | 1 3.57 17.86 Keryx Biopharmaceuticals, Inc. | 1 3.57 21.43 L3 Security & Detection | 1 3.57 25.00 Medline Industries Inc | 1 3.57 28.57 Ortho-Clinical Diagnostics | 1 3.57 32.14 Orthofix Srl | 1 3.57 35.71 Pharmedium Services, LLC | 3 10.71 46.43 Philips Electronics North America Co.. | 1 3.57 50.00 Randox Laboratories Ltd. | 1 3.57 53.57 Remel Inc | 1 3.57 57.14 SSM Health Care St. Louis DBA SSM St... | 10 35.71 92.86 Simple Diagnostics, Inc. | 1 3.57 96.43 Sterilmed Inc | 1 3.57 100.00 ----------------------------------------+----------------------------------- Total | 28 100.00 Frequencies for address1 variable in enfrep20180103 dataset : Address1 | Freq. Percent Cum. -----------------------------+----------------------------------- 1 Marina Park Dr Fl 12 | 1 3.57 3.57 100 Bayer Blvd | 1 3.57 7.14 1015 Bowles Ave | 10 35.71 42.86 10E Commerce Way | 1 3.57 46.43 11555 Heron Bay Blvd Ste 200 | 1 3.57 50.00 12076 Santa Fe Trail Dr | 1 3.57 53.57 1240 Deming Way | 4 14.29 67.86 150 N Field Dr Ste 350 | 3 10.71 78.57 3000 Minuteman Rd | 1 3.57 82.14 5010 Cheshire Pkwy N Ste 2 | 1 3.57 85.71 513 Technology Blvd | 1 3.57 89.29 55 Diamond Road | 1 3.57 92.86 Three Lakes Drive | 1 3.57 96.43 Via Delle Nazioni 9 | 1 3.57 100.00 -----------------------------+----------------------------------- Total | 28 100.00 Frequencies for address2 variable in enfrep20180103 dataset : Address2 | Freq. Percent Cum. ------------+----------------------------------- . | 28 100.00 100.00 ------------+----------------------------------- Total | 28 100.00 Frequencies for city variable in enfrep20180103 dataset : City | Freq. Percent Cum. ----------------+----------------------------------- Andover | 1 3.57 3.57 Boston | 1 3.57 7.14 Bussolengo | 1 3.57 10.71 Coral Springs | 1 3.57 14.29 Crumlin (North) | 1 3.57 17.86 Fenton | 10 35.71 53.57 Lake Forest | 3 10.71 64.29 Lenexa | 1 3.57 67.86 Madison | 4 14.29 82.14 Minneapolis | 1 3.57 85.71 Northfield | 1 3.57 89.29 Rochester | 1 3.57 92.86 Whippany | 1 3.57 96.43 Woburn | 1 3.57 100.00 ----------------+----------------------------------- Total | 28 100.00 Frequencies for stateprovince variable in enfrep20180103 dataset : State/Provi | nce | Freq. Percent Cum. ------------+----------------------------------- | 2 7.14 7.14 FL | 1 3.57 10.71 IL | 4 14.29 25.00 KS | 1 3.57 28.57 MA | 3 10.71 39.29 MN | 1 3.57 42.86 MO | 10 35.71 78.57 NJ | 1 3.57 82.14 NY | 1 3.57 85.71 WI | 4 14.29 100.00 ------------+----------------------------------- Total | 28 100.00 Frequencies for postalcode variable in enfrep20180103 dataset : Postal Code | Freq. Percent Cum. ------------+----------------------------------- | 2 7.14 7.14 01801-1044 | 1 3.57 10.71 01810-1032 | 1 3.57 14.29 02210-1832 | 1 3.57 17.86 07981-1544 | 1 3.57 21.43 14626-3601 | 1 3.57 25.00 33076-3362 | 1 3.57 28.57 53717-1954 | 4 14.29 42.86 55446-4101 | 1 3.57 46.43 60045-2506 | 3 10.71 57.14 60093 | 1 3.57 60.71 63026-2394 | 10 35.71 96.43 66215-3519 | 1 3.57 100.00 ------------+----------------------------------- Total | 28 100.00 Frequencies for country variable in enfrep20180103 dataset : Country | Freq. Percent Cum. --------------+----------------------------------- Ireland | 1 3.57 3.57 Italy | 1 3.57 7.14 United States | 26 92.86 100.00 --------------+----------------------------------- Total | 28 100.00 Frequencies for voluntarymandated variable in enfrep20180103 dataset : Voluntary/Mandated | Freq. Percent Cum. --------------------------+----------------------------------- FDA Mandated | 1 3.57 3.57 Voluntary: Firm Initiated | 27 96.43 100.00 --------------------------+----------------------------------- Total | 28 100.00 Frequencies for initialfirmnotificationofconsign variable in enfrep20180103 dataset : Initial Firm Notification of Consignee | or Public | Freq. Percent Cum. ----------------------------------------+----------------------------------- E-Mail | 12 42.86 42.86 Letter | 11 39.29 82.14 Press Release | 1 3.57 85.71 Telephone | 3 10.71 96.43 Two or more of the following: Email, .. | 1 3.57 100.00 ----------------------------------------+----------------------------------- Total | 28 100.00 Frequencies for distributionpattern variable in enfrep20180103 dataset : Distribution Pattern | Freq. Percent Cum. ----------------------------------------+----------------------------------- Distributed nationwide in the USA | 1 3.57 3.57 Nationwide. | 3 10.71 14.29 Natonwide | 1 3.57 17.86 Product was distributed throughout th.. | 1 3.57 21.43 Puerto Rico; International: Portugal,.. | 1 3.57 25.00 SSM Health entities in the state of M.. | 10 35.71 60.71 US Nationwide Distribution | 1 3.57 64.29 US Nationwide distribution in the sta.. | 1 3.57 67.86 USA (nationwide) Distribution.  Own.. | 1 3.57 71.43 Worldwide Distribution | 4 14.29 85.71 Worldwide Distribution - US Distribu.. | 1 3.57 89.29 Worldwide Distribution - US Nationwid.. | 1 3.57 92.86 Worldwide Distribution -- US, includi.. | 1 3.57 96.43 Worldwide Distribution and US Nationw.. | 1 3.57 100.00 ----------------------------------------+----------------------------------- Total | 28 100.00 Frequencies for recallnumber variable in enfrep20180103 dataset : Recall | Number | Freq. Percent Cum. ------------+----------------------------------- D-0130-2018 | 1 3.57 3.57 D-0131-2018 | 1 3.57 7.14 D-0132-2018 | 1 3.57 10.71 D-0133-2018 | 1 3.57 14.29 D-0134-2018 | 1 3.57 17.86 D-0135-2018 | 1 3.57 21.43 D-0136-2018 | 1 3.57 25.00 D-0137-2018 | 1 3.57 28.57 D-0138-2018 | 1 3.57 32.14 D-0139-2018 | 1 3.57 35.71 D-0140-2018 | 1 3.57 39.29 D-0141-2018 | 1 3.57 42.86 D-0142-2018 | 1 3.57 46.43 D-0143-2018 | 1 3.57 50.00 D-0144-2018 | 1 3.57 53.57 D-0145-2018 | 1 3.57 57.14 Z-0213-2018 | 1 3.57 60.71 Z-0270-2018 | 1 3.57 64.29 Z-0273-2018 | 1 3.57 67.86 Z-0285-2018 | 1 3.57 71.43 Z-0286-2018 | 1 3.57 75.00 Z-0287-2018 | 1 3.57 78.57 Z-0288-2018 | 1 3.57 82.14 Z-0289-2018 | 1 3.57 85.71 Z-0290-2018 | 1 3.57 89.29 Z-0291-2018 | 1 3.57 92.86 Z-0292-2018 | 1 3.57 96.43 Z-0295-2018 | 1 3.57 100.00 ------------+----------------------------------- Total | 28 100.00 Frequencies for classification variable in enfrep20180103 dataset : Classificat | ion | Freq. Percent Cum. ------------+----------------------------------- Class I | 1 3.57 3.57 Class II | 22 78.57 82.14 Class III | 5 17.86 100.00 ------------+----------------------------------- Total | 28 100.00 Frequencies for productdescription variable in enfrep20180103 dataset : Product Description | Freq. Percent Cum. ----------------------------------------+----------------------------------- , individually packaged in a Tyvek pl.. | 1 3.57 3.57 . Reprocessed device for single use .. | 1 3.57 7.14 Alcohol Prep Pads (Isopropyl Alcohol .. | 1 3.57 10.71 Amiodarone 900 mg in dextrose 5% 500 .. | 1 3.57 14.29 Auryxia (ferric citrate) tablets, 210.. | 1 3.57 17.86 Bayer Chewable Low Dose Aspirin 81 mg.. | 1 3.57 21.43 Fentanyl 10 mcg in 0.9% Sodium Chlori.. | 1 3.57 25.00 Fentanyl 2 mcg/mL and ropivacaine 0.2.. | 1 3.57 28.57 HYDROmorphone 10 mg in 0.9% Sodium Ch.. | 1 3.57 32.14 HYDROmorphone HCl in 0.9% Sodium Chlo.. | 1 3.57 35.71 Hi-Art(R) System, Model Number H-000-.. | 1 3.57 39.29 IntelliVue Multi Measurement Server, .. | 1 3.57 42.86 L3 Security & Detection System Cabine.. | 1 3.57 46.43 Morphine 50 mg in 0.9% Sodium Chlorid.. | 1 3.57 50.00 Neostigmine Methylsulfate 5 mg/5 mL, .. | 1 3.57 53.57 Norepinephrine 8 mg in dextrose 5% 25.. | 1 3.57 57.14 Orthofix Power Drill Torque Limiter, .. | 1 3.57 60.71 Oxytocin 30 units in 0.9% Sodium Chlo.. | 1 3.57 64.29 Phenylephrine 1000 mcg in 0.9% Sodium.. | 1 3.57 67.86 Remel Shigella sonnei Phase 1 & 2 Agg.. | 1 3.57 71.43 Rx series HbA1c REF/Catalog Number HA.. | 1 3.57 75.00 Succinylcholine chloride 100 mg in 5 .. | 1 3.57 78.57 TomoH(R) System, Model Number 1018284.. | 1 3.57 82.14 TomoHD(R) System, Model Number 101828.. | 1 3.57 85.71 TomoHDA(R) System, Model Number 10182.. | 1 3.57 89.29 VITROS Chemistry Products PHYT Slides.. | 1 3.57 92.86 morphine Sulfate in 0.9% Sodium Chlor.. | 1 3.57 96.43 morphine Sulfate in 0.9% Sodium Chlor.. | 1 3.57 100.00 ----------------------------------------+----------------------------------- Total | 28 100.00 Frequencies for productquantity variable in enfrep20180103 dataset : Product Quantity | Freq. Percent Cum. ---------------------------+----------------------------------- | 10 35.71 35.71 104,128 HDPE bottles | 1 3.57 39.29 112 devices | 1 3.57 42.86 118 units | 1 3.57 46.43 150,250 alcohol pads | 1 3.57 50.00 2,488 200-bottles | 1 3.57 53.57 237 units (single bottles) | 1 3.57 57.14 250 units | 1 3.57 60.71 29 units | 1 3.57 64.29 416 units | 1 3.57 67.86 471 | 1 3.57 71.43 5,722 units total | 1 3.57 75.00 7071 | 1 3.57 78.57 87 units | 1 3.57 82.14 90 kits | 1 3.57 85.71 US; 4680; Foreign: 1286 | 1 3.57 89.29 Unknown | 3 10.71 100.00 ---------------------------+----------------------------------- Total | 28 100.00 Frequencies for reasonforrecall variable in enfrep20180103 dataset : Reason for Recall | Freq. Percent Cum. ----------------------------------------+----------------------------------- Distorted ST-Segment when using 12-Le.. | 1 3.57 3.57 Failed Stability Specifications | 1 3.57 7.14 Inadequate seal due to lack of adhesi.. | 1 3.57 10.71 L3 has determined in airport environm.. | 1 3.57 14.29 Labeling: Incorrect or Missing Lot an.. | 3 10.71 25.00 Lack of Assurance of Sterility and cG.. | 1 3.57 28.57 Lack of sterility assurance: Microbia.. | 2 7.14 35.71 Lack of sterility assurance: Microbia.. | 8 28.57 64.29 Presence of Foreign Substance: Report.. | 1 3.57 67.86 Product did not undergo correct steri.. | 1 3.57 71.43 Randox confirmed low calibration abso.. | 1 3.57 75.00 The firm identified the potential for.. | 1 3.57 78.57 The power drill torque limiter may br.. | 1 3.57 82.14 The serum may fail to agglutinate wit.. | 1 3.57 85.71 Uncontrolled couch Z-axis movement (d.. | 4 14.29 100.00 ----------------------------------------+----------------------------------- Total | 28 100.00 Frequencies for centerclassificationdate variable in enfrep20180103 dataset : Center | Classificat | ion Date | Freq. Percent Cum. ------------+----------------------------------- 12/22/2017 | 6 21.43 21.43 12/26/2017 | 7 25.00 46.43 12/27/2017 | 2 7.14 53.57 12/28/2017 | 13 46.43 100.00 ------------+----------------------------------- Total | 28 100.00 Frequencies for terminationdate variable in enfrep20180103 dataset : Termination | Date | Freq. Percent Cum. ------------+----------------------------------- . | 28 100.00 100.00 ------------+----------------------------------- Total | 28 100.00 Frequencies for codeinfo variable in enfrep20180103 dataset : Code Info | Freq. Percent Cum. ----------------------------------------+----------------------------------- Lot # AH3842 | 1 3.57 3.57 Lot # NAA3T0X; Exp. 07/18 | 1 3.57 7.14 Lot # SD2070420925 Exp. Date 09/2019,.. | 1 3.57 10.71 Lot, exp: 170614-007, 9/12/2017; 1706.. | 1 3.57 14.29 Lot, exp: 170615-004, 9/13/2017; 1707.. | 1 3.57 17.86 Lot, exp: 170619-011, 9/17/2017; 1707.. | 1 3.57 21.43 Lot, exp: 170620-005, 9/18/2017; 1706.. | 1 3.57 25.00 Lot, exp: 170621-008, 09/19/2017; 170.. | 1 3.57 28.57 Lot, exp: 170622-007, 9/20/2017; 1707.. | 1 3.57 32.14 Lot, exp: 170627-012, 9/25/2017; 1706.. | 1 3.57 35.71 Lot/Batch 414553, expiry 28th Jan 2019 | 1 3.57 39.29 Lot: 170614-006, exp 9/12/2017 | 1 3.57 42.86 Lot: 170705-002, 10/03/2017 | 1 3.57 46.43 Lot: 170711-005, 10/09/2017 | 1 3.57 50.00 Lot: 172360026C; Exp. 11/23/2017 | 1 3.57 53.57 Lot: 172410025C; Exp. 11/27/2017 | 1 3.57 57.14 Lot:172410028C; Exp. 11/28/2017 Lot.. | 1 3.57 60.71 Model #: M300IA/AL, M3002A, M8102A, M.. | 1 3.57 64.29 Model No. DYNJ05914, Lots: 17GB3101, .. | 1 3.57 67.86 Model No. STJ408309, STJ408310, STJ40.. | 1 3.57 71.43 Model Number : Examiner 3DX 6000 cabi.. | 1 3.57 75.00 Power Drill Torque Limiter: Product C.. | 1 3.57 78.57 Serial Numbers: 110016 110022 1100.. | 1 3.57 82.14 Serial Numbers: 110033 110137 11015.. | 1 3.57 85.71 Serial Numbers: 110040 110083 11016.. | 1 3.57 89.29 Serial Numbers: 110081 110100 11015.. | 1 3.57 92.86 UDI 50560805009592. Kit lot #1465529.. | 1 3.57 96.43 Unique Identifier Number ( UDI) 1075.. | 1 3.57 100.00 ----------------------------------------+----------------------------------- Total | 28 100.00 Frequencies for recallinitiationdate variable in enfrep20180103 dataset : Recall | Initiation | Date | Freq. Percent Cum. ------------+----------------------------------- 02jun2017 | 1 3.57 3.57 07jun2017 | 1 3.57 7.14 12jun2017 | 1 3.57 10.71 05jul2017 | 1 3.57 14.29 18jul2017 | 1 3.57 17.86 10aug2017 | 10 35.71 53.57 23aug2017 | 1 3.57 57.14 05sep2017 | 1 3.57 60.71 26sep2017 | 3 10.71 71.43 27oct2017 | 1 3.57 75.00 10nov2017 | 1 3.57 78.57 17nov2017 | 4 14.29 92.86 08dec2017 | 1 3.57 96.43 12dec2017 | 1 3.57 100.00 ------------+----------------------------------- Total | 28 100.00 Frequencies for recallinitiationdatestr variable in enfrep20180103 dataset : Recall | Initiation | Date | Freq. Percent Cum. ------------+----------------------------------- 06/02/2017 | 1 3.57 3.57 06/07/2017 | 1 3.57 7.14 06/12/2017 | 1 3.57 10.71 07/05/2017 | 1 3.57 14.29 07/18/2017 | 1 3.57 17.86 08/10/2017 | 10 35.71 53.57 08/23/2017 | 1 3.57 57.14 09/05/2017 | 1 3.57 60.71 09/26/2017 | 3 10.71 71.43 10/27/2017 | 1 3.57 75.00 11/10/2017 | 1 3.57 78.57 11/17/2017 | 4 14.29 92.86 12/08/2017 | 1 3.57 96.43 12/12/2017 | 1 3.57 100.00 ------------+----------------------------------- Total | 28 100.00 Frequencies for reportdate variable in enfrep20180103 dataset : Report Date | Freq. Percent Cum. ------------+----------------------------------- 03jan2018 | 28 100.00 100.00 ------------+----------------------------------- Total | 28 100.00 Frequencies for reportdatestr variable in enfrep20180103 dataset : Report Date | Freq. Percent Cum. ------------+----------------------------------- 01/03/2018 | 28 100.00 100.00 ------------+----------------------------------- Total | 28 100.00 by Jean Roth , jroth@nber.org , 25 Jan 2018