BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 97388 · Received February 15, 1995

    Report

    Report Number
    97388
    Event Type
    Injury
    Date Received
    February 15, 1995
    Date of Event
    October 31, 1994
    Report Date
    December 2, 1994
    Manufacturer
    DOW CORNING CORP.
    Product Code
    KWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH RHEUMATOID ARTHRITIS S/P WITH A SWANSON SILASTIC IMPLANT OF THE LEFT WRIST 11 YRS AGO. SHE WAS FOUND TO HAVE A FRACTURED SILASTIC IMPLANT IN 4/94 AND CONSENTED TO REMOVAL OF THE IMPLANT AND FUSION OF THE WRIST. DURING SURGERY, THE SILICONE IMPLANT WAS NOTED TO BE IN ONE PLACE BUT THERE WERE FRACTURES NOTED AROUND THE COLLARS OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK Implant SILASTIC WRIST IMPLANT KWM DOW CORNING CORP. UNK. UNK.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention