BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC IMPLANT

    MDR report key: 26610 · Received August 3, 1995

    Report

    Report Number
    26610
    Event Type
    Injury
    Date Received
    August 3, 1995
    Date of Event
    May 10, 1995
    Report Date
    May 11, 1995
    Manufacturer
    WRIGHT DOW CORNING
    Product Code
    KWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WRIST IMPLANT REMOVED DUE TO BREAKAGE OF DEVICE. IMPLANTED 6 YRS AGO. PT DENIES HISTORY OF TRAUMA/INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC IMPLANT WRIST IMPLANT KWM WRIGHT DOW CORNING HH126320

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| O