BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 6401795 · Received March 14, 2017

    Report

    Report Number
    3002808486-2017-00787
    Event Type
    Death
    Date Received
    March 14, 2017
    Report Date
    February 25, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    EKSEMPEL PÅ H10 ¿ SLET TING ALLEREDE SKREVET I RAPPORTEN EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). A2) UNKNOWN AS INFORMATION WAS NOT PROVIDED. A4) UNKNOWN AS INFORMATION WAS NOT PROVIDED. B3) UNKNOWN AS INFORMATION WAS NOT PROVIDED. D1) UNKNOWN AS INFORMATION WAS NOT PROVIDED. D4) LOT#: UNKNOWN AS INFORMATION WAS NOT PROVIDED. CATALOG#: UNKNOWN BUT REFERRED TO AS AN IVC FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. D6) UNKNOWN AS INFORMATION WAS NOT PROVIDED F9) UNKNOWN AS LOT# IS UKNOWN G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. H4) UNKNOWN AS LOT# IS UNKNOWN. (B)(4). IT HAS NOT BEEN POSSIBLE TO INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE. COOK WILL REOPEN ITS INVESTIGATION AFTER FURTHER INFORMATION IS RECEIVED AND WILL SUPPLEMENT IN ACCORDANCE WITH 21 C.F.R.803.56 WHEN APPROPRIATE. IT IS UNKNOWN, IF REPORTED PATIENT DEATH IN ANY WAY RELATED TO THE FILTER. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IT IS ALLEGED THAT "[PT] WAS IMPLANTED WITH AN IVC FILTER AND SUFFERED PRE-DEATH INJURIES AND/OR DEATH." PATIENT OUTCOME: ALLEGED THAT [PT] "HAVE SUFFERED PERMANENT AND CONTINUOUS INJURIES, PAIN AND SUFFERING, DISABILITY AND IMPAIRMENT. [PT] HAVE SUFFERED EMOTIONAL TRAUMA, HARM AND INJURIES THAT WILL CONTINUE INTO THE FUTURE. [PT] HAVE LOST THEIR ABILITY TO LIVE A NORMAL LIFE, AND WILL CONTINUE TO BE SO DIMINISHED INTO THE FUTURE. FURTHERMORE, [PT] HAVE LOST EARNINGS AND WILL CONTINUE TO LOSE EARNINGS INTO THE FUTURE AND HAVE MEDICAL BILLS BOTH PAST AND FUTURE RELATED TO CARE BECAUSE OF THE IVC FILTERS¿ DEFECTS." [PT] IS DECEASED. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG #: UNKNOWN BUT REFERRED TO AS AN IVC FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. MFR DATE UNKNOWN AS LOT # IS UNKNOWN. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IT IS ALLEGED THAT "[PT] WAS IMPLANTED WITH AN IVC FILTER AND SUFFERED PRE-DEATH INJURIES AND/OR DEATH." PATIENT OUTCOME: ALLEGED THAT [PT] "HAVE SUFFERED PERMANENT AND CONTINUOUS INJURIES, PAIN AND SUFFERING, DISABILITY AND IMPAIRMENT. [PT] HAVE SUFFERED EMOTIONAL TRAUMA, HARM AND INJURIES THAT WILL CONTINUE INTO THE FUTURE. [PT] HAVE LOST THEIR ABILITY TO LIVE A NORMAL LIFE, AND WILL CONTINUE TO BE SO DIMINISHED INTO THE FUTURE. FURTHERMORE, [PT] HAVE LOST EARNINGS AND WILL CONTINUE TO LOSE EARNINGS INTO THE FUTURE AND HAVE MEDICAL BILLS BOTH PAST AND FUTURE RELATED TO CARE BECAUSE OF THE IVC FILTERS¿ DEFECTS." [PT] IS DECEASED. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186258 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death