BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMBINATION GEL-INFLATABLE MAMMARY PROSTHESIS

    MDR report key: 150016 · Received February 18, 1998

    Report

    Report Number
    6000080-1998-00263
    Event Type
    Injury
    Date Received
    February 18, 1998
    Date of Event
    February 2, 1981
    Report Date
    February 2, 1998
    Manufacturer
    AMERICAN HEYER-SCHULTE
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBINATION GEL-INFLATABLE MAMMARY PROSTHESIS Implant BREAST IMPLANT FTR AMERICAN HEYER-SCHULTE STYLE 7000 202514

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other