BEUDAMED
    FDA Adverse Event Summary report: N

    HEYER-SCHULTE BREAST IMPLANT

    MDR report key: 12747 · Received April 14, 1994

    Report

    Report Number
    MW1001587
    Date Received
    April 14, 1994
    Manufacturer
    V MUELLER DIV. BAXTER HEALTHCARE CORP.
    Product Code
    FWM
    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 1001588.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE BREAST IMPLANT Implant BREAST IMPLANT FWM V MUELLER DIV. BAXTER HEALTHCARE CORP. 1800

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR