BEUDAMED
    FDA Adverse Event Summary report: N

    HEYER-SCHULTE DOUBLE LUMEN BREAST IMPLANT

    MDR report key: 12748 · Received April 14, 1994

    Report

    Report Number
    MW1001588
    Date Received
    April 14, 1994
    Manufacturer
    MENTOR CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LEAKING OR RUPTURED BREAST IMPLANTS. RPTR HAD THESE IMPLANTS ON 5/26/83. LEFT WAS REPLACED ON 6/1/83 WITH SAME TYPE OF IMPLANT. THE RIGHT ONE WAS REPLACED WITH A DOUBLE LUMEN IMPLANT ON 8/2/85. BOTH IMPLANTS WERE EXPLANTED ON 4/13/92. (SEE ALSO 1001587.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE DOUBLE LUMEN BREAST IMPLANT Implant BREAST IMPLANT FTR MENTOR CORP. 1800

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR