BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGHAN MEDICAL CORP

    MDR report key: 51106 · Received November 20, 1996

    Report

    Report Number
    51106
    Event Type
    Malfunction
    Date Received
    November 20, 1996
    Date of Event
    November 14, 1996
    Report Date
    November 19, 1996
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RUPTURED SILICONE BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN MEDICAL CORP Implant SILICONE BREAST IMPLANT FTR MCGHAN MEDICAL CORP. UNK AB7984

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other