BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLOK REMOVER XL/L

    MDR report key: 1707197 · Received May 27, 2010

    Report

    Report Number
    1044475-2010-00053
    Event Type
    Malfunction
    Date Received
    May 27, 2010
    Date of Event
    April 15, 2010
    Report Date
    April 29, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HBQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS 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: THE HANDLE SNAPPED OFF DURING A PROCEDURE. NO FURTHER INFO IS AVAILABLE. 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 2101307-030

    Patients

    Seq Age Sex Outcome Treatment
    1