BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WECK HEMOCLIP APPLIER, MED 8" CVD

    MDR report key: 1880274 · Received October 19, 2010

    Report

    Report Number
    1044475-2010-00138
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    July 7, 2010
    Report Date
    October 5, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    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. 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. IT WAS REPORTED THAT THE PT WHO HAD CORONARY BYPASS SURGERY RETURNED TO THE OPERATING ROOM AFTER SEVERAL HOURS FOR BLEEDING, WHERE IT WAS DISCOVERED THE CLIP HAD SLIPPED OFF THE SAPHENOUS VEIN GRAFT IN THE HEART. THE REPORTER STATED THE PT SUFFERED A NEUROLOGICAL DEFICIT POST OPERATIVELY. THE PT'S CURRENT CONDITION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEMOCLIP APPLIER, MED 8" CVD CLIP APPLIER FZP TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R