BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-FILLED MAMMARY PROSTHESIS

    MDR report key: 121998 · Received September 22, 1997

    Report

    Report Number
    6000080-1997-00379
    Event Type
    Injury
    Date Received
    September 22, 1997
    Date of Event
    October 4, 1978
    Report Date
    September 5, 1997
    Manufacturer
    AMERICAN HEYER-SCHULTE
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 GEL-FILLED MAMMARY PROSTHESIS Implant BREAST IMPLANT FTR AMERICAN HEYER-SCHULTE STYLE 6000 150654

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other