BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST IMPLANT, 230 CC

    MDR report key: 10995 · Received January 21, 1994

    Report

    Report Number
    MW1000432
    Event Type
    Injury
    Date Received
    January 21, 1994
    Report Date
    January 10, 1994
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD BREAST IMPLANT SURGERY IN 1982 TO CORRECT A BIRTH DEFECT. WITHIN SEVERAL YRS, SHE DEVELOPED CAPSULAR CONTRACTION IN LEFT BREAST, TO THE POINT WHERE IT WAS PAINFUL TO SLEEP ON HER STOMACH. IN 1989, RPTR HAD THE LEFT BREAST IMPLANT REMOVED AND REPLACED WITH A DIFFERENT BRAND IMPLANT WITH THE HOPE OF PREVENTING THE CAPSULAR CONTRACTION. WITHIN A COUPLE OF YRS, THE SAME PROBLEM DEVELOPED IN LEFT BREAST. DATE EVENT OCCURRED: 1984 AND 1990. (ALSO SEE MEDWATCH 1000433.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREAST IMPLANT, 230 CC Implant FTR DOW CORNING CORP. HH068134

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention