BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEM-O-LOK ENDO REMOVER 5MM

    MDR report key: 1880949 · Received October 5, 2010

    Report

    Report Number
    1044475-2010-00137
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE FOR INVESTIGATION HAS BEEN REC'D, BUT INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE JAW CAME APART WHILE DEMONSTRATING USE. NO PT INJURY REPORTED OR INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEM-O-LOK ENDO REMOVER 5MM ENDO CLIP REMOVER FZP TELEFLEX MEDICAL NA 0800533-001

    Patients

    Seq Age Sex Outcome Treatment
    1