BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HZ APPLIER SMALL WIDE 8" CVD

    MDR report key: 2260239 · Received August 31, 2011

    Report

    Report Number
    1044475-2011-00094
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 19, 2011
    Manufacturer
    TELEFLEX
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE REC'D BY MFR, BUT INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: CLIP DIDN'T HOLD CORRECTLY IN APPLIER. IT WAS REPORTED THAT THIS OCCURRED DURING A CABG PROCEDURE. THE NURSE THINKS WHEN THE DOCTOR WENT TO CLOSE THE VESSEL, THE CLIP WAS NOT SEATED PROPERLY ON THE APPLIER AND ENDED UP WITH THE JAW OF THE APPLIER SLIGHTLY NICKING THE VESSEL. ADD'L INFO REQUESTED. PT CURRENT CONDITION UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HZ APPLIER SMALL WIDE 8" CVD APPLIER FZP TELEFLEX 790351-036

    Patients

    Seq Age Sex Outcome Treatment
    1