BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM SURGICLIP S-9.0 TITANIUM

    MDR report key: 2062578 · Received April 8, 2011

    Report

    Report Number
    2647580-2011-00241
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 17, 2011
    Manufacturer
    USSC PUERTO RICO, INC.
    Product Code
    FZP
    PMA / PMN Number
    K853650
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: THYROIDECTOMY. ACCORDING TO THE REPORTER: DURING THE CASE, THE STAPLES FLY OFF OR CUT THE VESSELS.

    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, INC. P0K1140

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability