BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGHAN MEDICAL CORP.

    MDR report key: 542900 · Received September 7, 2004

    Report

    Report Number
    542900
    Event Type
    Malfunction
    Date Received
    September 7, 2004
    Date of Event
    September 3, 2004
    Report Date
    September 7, 2004
    Manufacturer
    MCGHAN MEDICAL CORP
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BREAST AUGMENTATION-SALINE FILLED DONE IN 2000. RIGHT IMPLANT DEFLATED. BOTH IMPLANTS REMOVED. NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN MEDICAL CORP. SALINE FILLED BREAST IMPLANT BILATERAL FWM MCGHAN MEDICAL CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other IMPLANTS TAKE BY DOCTOR FOR RETURN TO MFR.