BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN MEDICAL CORP.

    MDR report key: 488204 · Received September 22, 2003

    Report

    Report Number
    MW1029627
    Event Type
    Injury
    Date Received
    September 22, 2003
    Date of Event
    July 11, 2003
    Report Date
    September 4, 2003
    Manufacturer
    MCGHAN MEDIAL CORP. (INAMED)
    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 - LEFT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN MEDICAL CORP. MAMMARY IMPLANT FWM MCGHAN MEDIAL CORP. (INAMED) STYLE 168 KZ2355

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| O