BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE-FILLED MAMMARY PROSTHESIS

    MDR report key: 16691 · Received October 7, 1994

    Report

    Report Number
    MW1003636
    Event Type
    Injury
    Date Received
    October 7, 1994
    Date of Event
    March 18, 1981
    Report Date
    September 26, 1994
    Manufacturer
    MENTOR 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 TO REPLACE ANOTHER CO'S IMPLANTS ON 1/23/89. IN 11/89 SHE WAS DIAGNOSED WITH CHRONIC FATIGUE SYNDROME. IT IS WORSE CAUSING NUMEROUS PROBLEMS. SHE ALSO HAS PANIC DOSORDER, DEPRESSION AND LOW IMMUNITY. HER INITIAL SURGERY WAS AN 80% MASTECTOMY ON 3/18/81 DUE TO FIBROCYSTIC DISEASE/SCLEROSIS AND ANOTHER CO'S IMPLANTS WERE IMPLANTED. (SAME RPTR REFERRED TO IN 1003635, 1003637 AND 1003638).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE-FILLED MAMMARY PROSTHESIS BREAST IMPLANT FWM MENTOR CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Disability