BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-FILLED MAMMARY PROSTHESIS

    MDR report key: 163055 · Received April 17, 1998

    Report

    Report Number
    6000080-1998-00970
    Event Type
    Injury
    Date Received
    April 17, 1998
    Date of Event
    November 1, 1973
    Report Date
    April 3, 1998
    Manufacturer
    AMERICAN HEYER-SCHULTE
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDWATCH 1013339 THAT THE CONSUMER EXPERIENCED VARIOUS ILLNESSES.

    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