BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WECK HEMOCLIP SMALL

    MDR report key: 1880293 · Received October 19, 2010

    Report

    Report Number
    3003898360-2010-00451
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 2, 2010
    Report Date
    October 5, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K841547
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OUTCOMES ATTRIBUTED TO ADVERSE EVENT. OTHER SERIOUS - THE PT WAS RETURNED TO THE OPERATING ROOM BECAUSE OF BLEEDING. IT IS REPORTED THAT THE PT HAS HAD A POOR NEUROLOGICAL OUTCOME. THE SAMPLE DEVICE HAS NOT BEEN RECEIVED AT TIME OF THIS REPORT, THEREFORE, THE INVESTIGATION IS INCOMPLETE. A F/U INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ADD'L INFO WAS RECEIVED 10/05/2010. CLIP SLIPPED OFF POST OPERATIVELY ON TWO OCCASIONS IN A 12 HOUR TIME PERIOD. THE PT WAS RETURNED TO THE OPERATING ROOM BECAUSE OF THE BLEEDING. IT IS REPORTED THAT THE PT HAS SUBSEQUENTLY DEMONSTRATED SYMPTOMS OF COGNITIVE DYSFUNCTION. MEDIUM AND SMALL HEMOCLIPS WERE USED FOR THE PROCEDURE. ANOTHER MDR REPORT WILL BE SENT FOR THE MEDIUM HEMOCLIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEMOCLIP SMALL HEM-O-LOK CLIPS FZP TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R