BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITEK HIGH PROFILE LO BLEED

    MDR report key: 1133903 · Received August 22, 2008

    Report

    Report Number
    MW5008071
    Event Type
    Injury
    Date Received
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 1989, BILATERAL AUGMENTATION WITH SURGITEK HIGH PROFILE ROUND SCL TO BLEED IMPLANTS 310CC. IN 2008, PT UNDERWENT BILATERAL CAPSULECTOMY AND IMPLANT REMOVAL. BOTH IMPLANTS REMOVED INTACT. PT AUGMENTED WITH MENTOR MOD AND GEL IMPLANTS 400CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK HIGH PROFILE LO BLEED SILICONE MAMMARY IMPLANTS FTR MEDICAL ENGINEERING CORP. 50175-89A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention