BEUDAMED
    FDA Adverse Event Injury Summary report: N

    133650 PREMIUM SURGICLIP III 9.0

    MDR report key: 5457344 · Received February 24, 2016

    Report

    Report Number
    2647580-2016-00084
    Event Type
    Injury
    Date Received
    February 24, 2016
    Report Date
    February 15, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    FZP
    PMA / PMN Number
    K142869
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. A SUPPLEMENTAL WILL BE SUBMITTED UPON RECEIPT OF ANY NEW INFORMATION

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE CLIPS HAVE DAMAGED THE VESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114153 133650 PREMIUM SURGICLIP III 9.0 CLIP, IMPLANTABLE FZP COVIDIEN, FORMERLY USSC PUERTO RICO INC 133650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other