BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN MEDICAL CORP

    MDR report key: 291162 · Received August 16, 2000

    Report

    Report Number
    MW1019680
    Event Type
    Injury
    Date Received
    August 16, 2000
    Report Date
    August 8, 2000
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AUGMENTED WITH MCGHAN STYLE 168 SALINE MAMMARY IMPLANTS BILATERALLY. OFFICE VISIT OVER LAST 3 WEEKS HAS NOTICED DEFLATION OF RT IMPLANT. PT UNDERWENT REMOVAL OF DEFLATED RT IMPLANT AND PARTIAL CAPSULECTOMY. ALSO REMOVAL OF LT IMPLANT AND PARTIAL CAPSULECTOMY. LEFT IMPLANT WAS CUT BY SURGEON, DEFLATED AND REMOVED INTACT. RT IMPLANT ALSO REMOVED INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN MEDICAL CORP SALINE MAMMARY IMPLANTS FWM MCGHAN MEDICAL CORP. * GL2885, GG1262

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention