BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEMOLOK ENDO APPLIER 5MM

    MDR report key: 1900493 · Received October 29, 2010

    Report

    Report Number
    1044475-2010-00144
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 13, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE DEVICE HAS BEEN RECEIVED, BUT INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT. A F/U INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: APPLIER IS NOT TIGHTENING THE CLIP DOWN ON THE VESSELS OR TISSUE. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEMOLOK ENDO APPLIER 5MM CLIP APPLIER FZP TELEFLEX MEDICAL NA 04M0800148

    Patients

    Seq Age Sex Outcome Treatment
    1