BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEM-O-LOK ENDO 5

    MDR report key: 1172845 · Received September 17, 2008

    Report

    Report Number
    3003898360-2008-00088
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Report Date
    August 25, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE REQUESTED, BUT NOT RECEIVED. INVESTIGATION REPORT NOT AVAILABLE AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    INCIDENT REPORTED AS: DURING SAME SURGERY, THE HANDLE WAS BLOCKED. THREE APPLIERS DEFECTIVE. THIS REPORT IS FOR SECOND APPLIER. NO PATIENT INJURY AND/OR INTERVENTION REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEM-O-LOK ENDO 5 HEM-O-LOK GDO TELEFLEX MEDICAL NA 01B0800172

    Patients

    Seq Age Sex Outcome Treatment
    1