BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK AUTO ENDO5 APPLIER M/L

    MDR report key: 2050025 · Received March 31, 2011

    Report

    Report Number
    3003898360-2011-00129
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 9, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN REC'D BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE HANDLE STICKS, JAWS NOT HOLDING CLIPS. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK AUTO ENDO5 APPLIER M/L AUTO ENDO APPLIER FZP TELEFLEX MEDICAL NA 01D1000055

    Patients

    Seq Age Sex Outcome Treatment
    1