BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PILLING KNIFE HANDLE 3

    MDR report key: 2617791 · Received June 7, 2012

    Report

    Report Number
    1044475-2012-00059
    Event Type
    Malfunction
    Date Received
    June 7, 2012
    Report Date
    May 16, 2012
    Manufacturer
    TELEFLEX
    Product Code
    GDZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT BEEN RECEIVED BY MANUFACTURER IN TIME FOR THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: CUSTOMER ALLEGES IT IS VERY DIFFICULT TO BLADE ON AND OFF THE HANDLE. THIS WAS REPORTED BEFORE PT USE. NO REPORTED INJURY TO THE OPERATING ROOM PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLING KNIFE HANDLE 3 KNIFE HANDLE GDZ TELEFLEX H29135295019

    Patients

    Seq Age Sex Outcome Treatment
    1