BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMBINATION GEL-INFLATABLE MAMMARY PROSTHESIS

    MDR report key: 119205 · Received September 11, 1997

    Report

    Report Number
    6000080-1997-00277
    Event Type
    Injury
    Date Received
    September 11, 1997
    Date of Event
    April 23, 1979
    Report Date
    August 25, 1997
    Manufacturer
    AMERICAN HEYER-SCHULTE
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 COMBINATION GEL-INFLATABLE MAMMARY PROSTHESIS Implant BREAST IMPLANT FTR AMERICAN HEYER-SCHULTE STYLE 7000 161956

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other