BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIPLE LUMEN BREAST IMPLANT

    MDR report key: 10994 · Received January 21, 1994

    Report

    Report Number
    MW1000430
    Event Type
    Injury
    Date Received
    January 21, 1994
    Date of Event
    September 29, 1993
    Report Date
    January 11, 1994
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BILATERAL BREAST IMPLANTS IMPLANTED 12/7/89, AFTER MASTECTOMY. EXPLANTED 9/29/93. BOTH IMPLANTS HAD RUPTURED. (SAME RPTR AS IN MEDWATCH 1000430.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIPLE LUMEN BREAST IMPLANT Implant FTR MCGHAN MEDICAL CORP. STYLE 57

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention