BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK AUTO ENDO APPLIER

    MDR report key: 1083590 · Received July 29, 2008

    Report

    Report Number
    3003898360-2008-00060
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 8, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES HAVE BEEN REQUESTED, BUT HAVE NOT BEEN RECEIVED YET. ADDITIONAL INFO AND LOT# HAVE ALSO BEEN REQUESTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES, "THE APPLIER IS DEFECTIVE. IT DOES NOT ADVANCE THE CLIPS." NO PT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK AUTO ENDO APPLIER LIGATING APPLIER GDW TELEFLEX MEDICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1