BEUDAMED
    FDA Adverse Event Injury Summary report: N

    133650 PREMIUM SURGICLIP III 9.0

    MDR report key: 6091641 · Received November 9, 2016

    Report

    Report Number
    2647580-2016-00946
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    September 24, 2016
    Report Date
    October 17, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    FZP
    PMA / PMN Number
    K142869
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). ADDITIONAL ATTEMPTS TO OBTAIN INFORMATION AND THE DEVICE HAVE BEEN MADE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH NEW DETAILS IF THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT UNILATERAL NECK DISSECTION, OROPHARYNGEAL RESECTION AND FREE FLAT RECONSTRUCTION. PATIENT HAD A POST-OPERATIVE BLEED AT MORE THAN 24HRS POST OP. PATIENT WAS RETURNED TO THEATRE, WAS FOUND TO HAVE AN ARTERIAL BLEED FROM THE FACIAL ARTERY WHICH THE SURGICAL TEAM FEEL WAS LIKELY TO HAVE BEEN LIGATED WITH A SURGICAL CLIP. THE PRODUCT WAS NOT RESTERILISED PRIOR TO THIS INCIDENT. THERE WAS BLOOD LOSS OF MORE THAN 500CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741782 133650 PREMIUM SURGICLIP III 9.0 CLIP, IMPLANTABLE FZP COVIDIEN, FORMERLY USSC PUERTO RICO INC 133650

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention