BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM SURGICLIP S-9.0 TITANIUM

    MDR report key: 2232505 · Received August 25, 2011

    Report

    Report Number
    2647580-2011-00566
    Event Type
    Injury
    Date Received
    August 25, 2011
    Report Date
    August 16, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    FZP
    PMA / PMN Number
    K853650
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: BREAST AUGMENTATION. ACCORDING TO THE REPORTER: THE CLIPS COME OUT TWO BY TWO WHICH DAMAGE THEY MAMMARY ARTERIES NEEDED FOR THE BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM SURGICLIP S-9.0 TITANIUM DISPOSABLE CLIP APPLIER FZP USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other