BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGHAN MEDICAL CORP

    MDR report key: 276057 · Received April 28, 2000

    Report

    Report Number
    MW1018787
    Event Type
    Malfunction
    Date Received
    April 28, 2000
    Date of Event
    April 21, 2000
    Report Date
    April 27, 2000
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PAIN DUE TO CAPSULAR CONTRACTURE. RULE OUT RUPTURE OF THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN MEDICAL CORP BREAST IMPLANT FTR MCGHAN MEDICAL CORP. 220/260 CC AL3172

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other