BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLOK LIGATING CLIP

    MDR report key: 1052970 · Received May 27, 2008

    Report

    Report Number
    3003898360-2008-00031
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 10, 2008
    Report Date
    May 9, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES HAVE NOT BEEN RECEIVED BY THE MANUFACTURER YET. SHOULD THE SAMPLES BE RECEIVED, A COMPLETE FOLLOW UP REPORT WILL BE SENT AS SOON AS IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES " THE CLIPS DID NOT CLOSE PROPERLY ON THE VESSELS." NO CLINICAL CONSEQUENCE OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOLOK LIGATING CLIP LIGATING CLIP FZP TELEFLEX MEDICAL T156202

    Patients

    Seq Age Sex Outcome Treatment
    1