BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON APPLIER SMALL WIDE 8" CURVED

    MDR report key: 1791212 · Received August 5, 2010

    Report

    Report Number
    1044475-2010-00103
    Event Type
    Malfunction
    Date Received
    August 5, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED BY MFR, HOWEVER, THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U INVESTIGATION REPORT WILL BE SENT WHEN INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: CLIPS FALLING OUT OF THE APPLIER JAWS AFTER LOADING AND BEFORE SECURING TO VESSEL. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON APPLIER SMALL WIDE 8" CURVED LIGATING APPLIER FZP TELEFLEX MEDICAL NA 04L0700016

    Patients

    Seq Age Sex Outcome Treatment
    1