BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM SURGICLIP M-11.5 TITANIUM

    MDR report key: 2250021 · Received September 9, 2011

    Report

    Report Number
    2647580-2011-00610
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 30, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K853650
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: BREAST AUGMENTATION. ACCORDING TO THE REPORTER: THE DEVICE TORE THE TISSUE AND VESSELS WHILE FIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM SURGICLIP M-11.5 TITANIUM DISPOSABLE CLIP APPLIER GDW USSC PUERTO RICO P1D0333

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Disability