BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM SURGICLIP S-9.0 TITANIUM

    MDR report key: 3981495 · Received July 25, 2014

    Report

    Report Number
    2647580-2014-00586
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    December 20, 2013
    Report Date
    July 23, 2014
    Manufacturer
    COVIDIEN, FORMERLY 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

    ACCORDING TO THE REPORTER: THE CLIPS WERE ON THE WRONG SIDE AND TORN OFF THE VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436625 PREMIUM SURGICLIP S-9.0 TITANIUM DISPOSABLE CLIP APPLIER FZP COVIDIEN, FORMERLY USSC PUERTO RICO, INC. P3H0273X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other