BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEYER-SCHULTE SALINE-FILLED MAMMARY PROSTHESIS

    MDR report key: 16690 · Received October 7, 1994

    Report

    Report Number
    MW1003635
    Event Type
    Injury
    Date Received
    October 7, 1994
    Date of Event
    March 18, 1981
    Report Date
    September 26, 1994
    Manufacturer
    V. MUELLER DIV. BAXTER HEALTHCARE CORP.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD BILATERAL BREAST IMPLANTS IMPLANTED ON 3/18/81. SHE HAD FIBROCYSTIC DISEASE/SCLEROSIS AND AN 80% MASTECTOMY. ON 1/23/89, THE RIGHT IMPLANT WAS EXCHANGED. IN 11/89 SHE WAS DIAGNOSED WITH CHRONIC FATIGUE SYNDROME, LOW IMMUNITY, PANIC DISORDER AND DEPRESSION. FIVE YEARS LATER SHE STILL HAS FATIGUE. IT IS WORSE, CAUSING NUMEROUS PROBLEMS. (SOME RPTR REFERRED TO IN 1003636-1003638).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE SALINE-FILLED MAMMARY PROSTHESIS BREAST IMPLANT FWM V. MUELLER DIV. BAXTER HEALTHCARE CORP. 209494, 226591

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Disability