BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN MEDICAL CORP.

    MDR report key: 498187 · Received November 12, 2003

    Report

    Report Number
    MW1030207
    Event Type
    Injury
    Date Received
    November 12, 2003
    Date of Event
    August 20, 2003
    Report Date
    September 22, 2003
    Manufacturer
    MCGHAN MEDICAL CORP
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS DEFLATION OF LEFT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN MEDICAL CORP. MAMMARY IMPLANT FWM MCGHAN MEDICAL CORP 27-168551 GV7983

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| O