BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEM-O-LOK ENDO 5

    MDR report key: 1052341 · Received May 23, 2008

    Report

    Report Number
    3003898360-2008-00033
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    December 10, 2007
    Report Date
    April 29, 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

    SAMPLE NOT AVAILABLE AT TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF SAMPLE BECOMES AVAILABLE OR IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE AUTOMATIC APPLIER DOES NOT DELIVER THE CLIPS. NO PATIENT INJURY OR INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEM-O-LOK ENDO 5 HEM-O-LOK GDO TELEFLEX MEDICAL T1218684

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK IF SAMPLE IS AVAILABLE