BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-FILLED MAMMARY PROSTHESIS

    MDR report key: 102371 · Received July 1, 1997

    Report

    Report Number
    6000001-1997-00772
    Event Type
    Injury
    Date Received
    July 1, 1997
    Date of Event
    August 15, 1977
    Report Date
    June 6, 1997
    Manufacturer
    AMERICAN HEYER-SCHULTE
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PLAINTIFF ALLEGES"...SUFFERED INJURIES AND DAMAGES...".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other