BEUDAMED
    FDA Adverse Event Death Summary report: N

    133650 PREMIUM SURGICLIP III 9.0

    MDR report key: 6083929 · Received November 7, 2016

    Report

    Report Number
    2647580-2016-00929
    Event Type
    Death
    Date Received
    November 7, 2016
    Date of Event
    July 7, 2016
    Report Date
    October 17, 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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HAS NOT BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SENT IF DEVICE IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A BILATERAL NECK DISSECTION. THE PATIENT HAD POST-OPERATIVE BLEEDING. THE PATIENT EXPIRED AS A RESULT OF AIRWAY OBSTRUCTION DUE TO THE BLEED. THE PRODUCT IS NOT BEING RETURNED. THE LOT NUMBER IS NOT AVAILABLE. THE COMPLAINT PRODUCT WAS USED ON A PATIENT. THERE WAS BLOOD LOSS OF OVER 500CC'S. THERE WAS NO EXTENSION OF THE INCISION BY MORE THAN 1 INCH. NO CHANGE FROM ENDOSCOPIC TO OPEN SURGERY. NO PORTION OF THE DEVICE OR TACK FELL INTO THE PATIENT CAVITY. THERE WAS NO UNANTICIPATED TISSUE LOSS OR IRREVERSIBLE DAMAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733934 133650 PREMIUM SURGICLIP III 9.0 CLIP, IMPLANTABLE FZP COVIDIEN, FORMERLY USSC PUERTO RICO INC 133650

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| O