BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GFX 460

    MDR report key: 11869878 · Received May 21, 2021

    Report

    Report Number
    MW5101490
    Event Type
    Injury
    Date Received
    May 21, 2021
    Report Date
    May 19, 2021
    Manufacturer
    MEDICORE CO. LTD.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AU
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE HAD MULTIPLE UNEXPLAINED HEALTH ISSUES OVER THE PAST 10 YRS, PRESENTED TO ER ON MANY OCCASIONS, HAD TESTS FOR THINGS SUCH AS MS AND BEEN DIAGNOSED WITH RAYNAUDS SYNDROME AND OTHER AUTO IMMUNE DISEASES. I HAD NO IDEA I WAS SUPPOSED TO HAVE MY IMPLANTS CHECKED EVERY YEAR BY ULTRASOUND. WHEN I FOUND OUT MY IMPLANTS HAD BEEN RECALLED, I GOT AN ULTRASOUND, AND THEY FOUND NO LEFT WAS RUPTURED. I FINALLY HAD THEM REMOVED A FEW DAYS AGO AS I TRULY BELIEVE THEY HAVE BEEN SLOWLY KILLING ME. (B)(6). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761040 GFX 460 PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MEDICORE CO. LTD. 016328 017751
    761041 GFX 460 PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MEDICORE CO. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| S