BEUDAMED
    FDA Adverse Event Death Summary report: N

    PREPEX

    MDR report key: 6137392 · Received December 1, 2016

    Report

    Report Number
    3011215095-2016-00712
    Event Type
    Death
    Date Received
    December 1, 2016
    Date of Event
    April 3, 2016
    Report Date
    December 1, 2016
    Manufacturer
    CIRC MEDTECH
    Product Code
    HFX
    PMA / PMN Number
    K103695
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PREPEX IS NOT SOLD NOR USED IN THE USA,THEREFORE THE MANUFACTURER HAS NOT REPORTED TO DATE. HOWEVER, THE COMPANY WAS REQUESTED BY THE FDA TO BEGIN REPORTING AND HAS DONE SUCH. THIS HAS CREATED A GAP BETWEEN THE DATE OF EVENT AND THE INITIAL REPORT. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    PREPEX IS NOT SOLD NOR USED IN THE USA,THEREFORE THE MANUFACTURER HAS NOT REPORTED TO DATE. HOWEVER, THE COMPANY WAS REQUESTED BY THE FDA TO BEGIN REPORTING AND HAS DONE SUCH. THIS HAS CREATED A GAP BETWEEN THE DATE OF EVENT AND THE INITIAL REPORT THE COMPANY HAS REVISED THE IFU TO INCLUDE WARNINGS REGARDING THE USE OF THE DEVICE IN A POPULATION THAT HAS NOT BEEN PROPERLY IMMUNIZED FOR TETANUS. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    PREPEX PLACEMENT: (B)(6) 2016. PREPEX REMOVAL: (B)(6) 2016. ON (B)(6) 2016 PATIENT WAS ADMITTED TO HOSPITAL AND DIAGNOSED WITH TETANUS FROM WHICH HE DIED.

    Description of Event or Problem · 1

    PREPEX PLACEMENT: (B)(6) 2016. PREPEX REMOVAL: (B)(6) 2016. ON (B)(6) 2016 PATIENT WAS ADMITTED TO HOSPITAL AND DIAGNOSED WITH TETANUS FROM WHICH HE DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789710 PREPEX PREPEX HFX CIRC MEDTECH

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Death