BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITEK

    MDR report key: 9785818 · Received March 3, 2020

    Report

    Report Number
    MW5093500
    Event Type
    Injury
    Date Received
    March 3, 2020
    Date of Event
    November 2, 1979
    Report Date
    February 28, 2020
    Manufacturer
    MEDICAL ENGINEERING CORPORATION / BRISTOL - MYERS SQUIBB
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    40 Y/O SILICONE SURGITEK IMPLANTS THAT HAVE RUPTURED AND LEAKING. HAVE HAD MANY HEALTH ISSUES AND STILL DO. NOW TRYING TO GET INSURANCE TO PAY FOR EXPLANT BEFORE I DIE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246474 SURGITEK PROSTHESIS, BREAST NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR MEDICAL ENGINEERING CORPORATION / BRISTOL - MYERS SQUIBB
    246475 SURGITEK PROSTHESIS, BREAST NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR MEDICAL ENGINEERING CORPORATION / BRISTOL - MYERS SQUIBB

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| S