BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGHAN MEDICAL CORP.

    MDR report key: 278522 · Received May 19, 2000

    Report

    Report Number
    278522
    Event Type
    Malfunction
    Date Received
    May 19, 2000
    Date of Event
    May 11, 2000
    Report Date
    May 19, 2000
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RIGHT SILICONE BREAST IMPLANT WAS LEAKING AND WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN MEDICAL CORP. (RIGHT) BREAST IMPLANT FTR MCGHAN MEDICAL CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other