BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLOK REMOVER XL/L

    MDR report key: 1675329 · Received April 20, 2010

    Report

    Report Number
    1044475-2010-00048
    Event Type
    Malfunction
    Date Received
    April 20, 2010
    Date of Event
    March 30, 2010
    Report Date
    March 30, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HBQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT BEEN RETURNED FOR INVESTIGATION. THE INVESTIGATION IS NOT COMPLETE AT THE TIME OF THIS REPORT. A FOLLOW UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: SURGEON IS HAVING DIFFICULTY REMOVING CLIPS WITH DEVICE. NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOLOK REMOVER XL/L CLIP REMOVER HBQ TELEFLEX MEDICAL NA 1516134-004

    Patients

    Seq Age Sex Outcome Treatment
    1