BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC (R) GREAT TOE IMPLANT H.P. (SWANSON DESIGN)

    MDR report key: 43321 · Received October 16, 1996

    Report

    Report Number
    43321
    Event Type
    Injury
    Date Received
    October 16, 1996
    Date of Event
    August 21, 1996
    Report Date
    August 26, 1996
    Manufacturer
    DOW CORNING CORP
    Product Code
    KWD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGES PT RECEIVED AN IMPLANT ON AN UNK DATE AND HAD REMOVAL ON AUG 21, 1996 BECAUSE THE "PIN BROKE REQUIRING SURGERY TO REMOVE IT AND REPAIR FOOT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC (R) GREAT TOE IMPLANT H.P. (SWANSON DESIGN) Implant GREAT TOE IMPLANT KWD DOW CORNING CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention