BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEM-O-LOK TAKEAPART ENDO APPLIER LG 10MM

    MDR report key: 1932098 · Received November 29, 2010

    Report

    Report Number
    1044475-2010-00156
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MFR, THEREFORE, THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE RETAINING BOLT AT THE HANDLE FELL OUT BEFORE USAGE AND THE APPLIER WAS NO LONGER FUNCTIONAL. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEM-O-LOK TAKEAPART ENDO APPLIER LG 10MM ENDO APPLIER FZP TELEFLEX MEDICAL NA 0941915-042

    Patients

    Seq Age Sex Outcome Treatment
    1