BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN MEDICAL CORP

    MDR report key: 661043 · Received December 28, 2005

    Report

    Report Number
    MW1037486
    Event Type
    Injury
    Date Received
    December 28, 2005
    Report Date
    December 19, 2005
    Manufacturer
    MCGHAN MEDICAL
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    APPROX SPONTANEOUS DEFLATION LEFT BREAST IMPLANT. TWELVE DAYS LATER PT UNDERWENT BILATERAL IMPLANT REMOVAL. LEFT IMPLANT WAS DEFLATED. PT AUGMENTED WITH SILICONE INPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN MEDICAL CORP SALINE FILLED MAMMARY IMPLANTS FWM MCGHAN MEDICAL STYLE 168 GM5981
    2 MCGHAN MEDICAL CORP SALINE FILLED MAMMORY IMPLANTS FWM MCGHAN MEDICAL STYLE 168 GM5980

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention