BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL MAMMARY PROSTHESIS

    MDR report key: 76101 · Received March 17, 1997

    Report

    Report Number
    6000001-1997-00321
    Event Type
    Injury
    Date Received
    March 17, 1997
    Date of Event
    June 10, 1982
    Report Date
    February 14, 1997
    Manufacturer
    AMERICAN HEYER SCHULTE
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PLAINTIFF REPORTS INITIAL IMPLANATATION OF THE LEFT IMPLANT 6/10/82. PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING BUT NOT LIMITED TO INJURIES TO JOINTS AND DISABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEL MAMMARY PROSTHESIS Implant BREAST IMPLANT FTR AMERICAN HEYER SCHULTE UNK 221470

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other