BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOW CORNING

    MDR report key: 751709 · Received August 10, 2005

    Report

    Report Number
    MW1036298
    Event Type
    Injury
    Date Received
    August 10, 2005
    Date of Event
    May 21, 2005
    Report Date
    August 3, 2005
    Manufacturer
    *
    Product Code
    KIG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAVING BEEN SEEN BY A DR WHO X-RAYED MY LEFT WRIST BECAUSE OF VARIOUS COMPLICATIONS, I.E., WRIST SPASMS, PROSTHESIS AND BONE CYSTS. DR LATER DETERMINED THIS WAS A CONDITION CALLED "SILICON SYNOVITIS." IMPLANT WAS REMOVED AND A "FOLL" BIOPSY WAS DONE. AWAITING RESULTS THAT ARE IN AND WILL SEND THEM UPON REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOW CORNING WRIST IMPLANT (SILICONE) KIG * UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Congenital Anomaly| H| O| R| S