BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-FILLED MAMMARY IMPLANT

    MDR report key: 26005 · Received September 25, 1995

    Report

    Report Number
    MW1007002
    Event Type
    Injury
    Date Received
    September 25, 1995
    Date of Event
    December 1, 1976
    Report Date
    September 14, 1995
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR COMPLAINED OF RUPTURED IMPLANTS AND HARDNESS. SHE HAD IMPLANTS PUT IN 12/76 DUE TO CYSTIC DISEASE OF BOTH BREASTS. THE PROBLEMS SHE HAS HAD SINCE ARE: MUSCLE AND PAIN SPASMS IN SHOULDERS AND BACK, ITCHING ON BREASTS, SHOULDERS AND STOMACH, HEADACHES, ACHING AND RESTLESS LEGS, SUPERFICIAL PHLEBITIS IN RIGHT LEG AND SWELLING OF KNEE THAT HAS NEVER LEFT, CHRONIC BLADDER PROBLEMS (NOT EMPTYING BLADDER COMPLETELY). SHE HAS HAD CATHETERIZE EVERY 6 HRS, & PUT MEDICINE IN HER BLADDER SINCE 1990. THE DR SAID SHE HAS A BAD BLADDER & NOTHING ELSE CAN BE DONE. SHE ALSO HAS LOSS OF MEMORY, SHE HAS INCREASING BLADDER INFECTIONS & CONNECTIVE TISSUE DISEASE. THE DRS SAID THE IMPLANTS WERE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEL-FILLED MAMMARY IMPLANT Implant SILICONE BREAST IMPLANT FTR DOW CORNING CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Disability