BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITEK PROPLAST

    MDR report key: 8068997 · Received November 13, 2018

    Report

    Report Number
    MW5081187
    Event Type
    Death
    Date Received
    November 13, 2018
    Date of Event
    January 1, 1982
    Report Date
    November 6, 2018
    Manufacturer
    UNK
    Product Code
    LZK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD THE VITEK PROPLAST IMPLANT AND WAS AT (B)(6) IN (B)(6) 2018 (5' 6 1/2"). SHE WAS UNABLE TO FIND ANYMORE TO HELP HER TREAT HER PAIN. HER BLOOD PRESSURE WAS AT 248/123 DUE TO PAIN. SHE HAD 38 FACIAL AND JAW SURGERIES TO TRY TO FIX THE PROPLAST DAMAGE. SHE ALSO HAD 32 OTHERS TO FIX HER CRUMBLING BODY FROM THE TEFLON FRAGMENTS. SHE HAD HORRENDOUS PAIN THROUGHOUT HER FACE, JAW AND BODY; 13 OF THE PROPLAST IMPLANTS BROKE / RUPTURED INSIDE HER. HER PAIN DR ABANDONED HER AS HE SAID SHE WAS TOO COMPLICATED. HE CUT HER OFF ALL PAIN AND MUSCLE RELAXERS. SHE WAS UNABLE TO EAT AS SHE DEVELOPED STRICTURES IN HER ESOPHAGUS. WATER WOULD NOT GO DOWN EITHER. SHE WOULD HAVE HER THROAT DILATED EVERY FEW MONTHS. HER HANDS WERE NOT ABLE TO BE USED AS SHE DEVELOPED SEVERE ARTHRITIS EVERYWHERE. PROPLAST RUINED HER LIFE. SHE HAD THE FIRST SURGERY AT THE AGE OF (B)(6) AND SHE DIED (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905539 VITEK PROPLAST IMPLANT, MALAR LZK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death