BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN MEDICAL CORP.

    MDR report key: 488195 · Received September 16, 2003

    Report

    Report Number
    MW1029585
    Event Type
    Injury
    Date Received
    September 16, 2003
    Date of Event
    July 9, 2003
    Report Date
    July 16, 2003
    Manufacturer
    MCGHAN MEDICAL 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 OF RIGHT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN MEDICAL CORP. MAMMARY IMPLANT, SALINE-FILLED FWM MCGHAN MEDICAL CORP. (INAMED) STYLE 168 HTB430

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| O