BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMARY PROSTHESIS

    MDR report key: 115537 · Received August 25, 1997

    Report

    Report Number
    6000080-1997-00137
    Event Type
    Injury
    Date Received
    August 25, 1997
    Date of Event
    September 5, 1973
    Report Date
    August 4, 1997
    Manufacturer
    AMERICAN HEYER-SCHULTE
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PLAINTIFF ALLEGES"..INJURIES AS A RESULT OF...IMPLANTS CONTAINING OR CONSISTING OF SILICONE, SILICONE GEL, AND/OR AN ELASTOMER MADE OF SILICONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMARY PROSTHESIS Implant BREAST IMPLANT FWM AMERICAN HEYER-SCHULTE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other