BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMARY PROSTHESIS

    MDR report key: 148983 · Received February 13, 1998

    Report

    Report Number
    6000080-1998-00205
    Event Type
    Injury
    Date Received
    February 13, 1998
    Report Date
    January 28, 1998
    Manufacturer
    AMERICAN HEYER-SCHULTE
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION TO PLAINTIFF 4/22/1998 PJD.

    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 MAMMARY PROSTHESIS Implant BREAST IMPLANT FTR AMERICAN HEYER-SCHULTE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other