BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEYER-SCHULTE SALINE-FILLED MAMMARY PROSTHESIS, 325 CC

    MDR report key: 16692 · Received October 7, 1994

    Report

    Report Number
    MW1003637
    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 THIS CO'S IMPLANTS IMPLANTED ON 2/21/84 TO REPLACE ANOTHER CO'S IMPLANTS. HER INITIAL SURGERY WAS AN 80% MASTECTOMY DUE TO FIBROCYSTIC DISEASE/SCLEROSIS. IN 11/89, SHE WAS DIAGNOSED WITH CHRONIC FATIGUE SYNDROME AND IT IS WORSE, CAUSING NUMEROUS PROBLEMS. SHE ALSO HAS LOW IMMUNITY PANIC DISORDER AND DEPRESSION. (SAME RPTR REFERRED TO IN 1003635, 1003636 AND 1003638).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE SALINE-FILLED MAMMARY PROSTHESIS, 325 CC BREAST IMPLANT FWM V. MUELLER DIV. BAXTER HEALTHCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Disability