BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK DISP. IMA/ENT 3/4" NEEDLE ELECTRODE

    MDR report key: 2616279 · Received June 4, 2012

    Report

    Report Number
    3003898360-2012-00216
    Event Type
    Malfunction
    Date Received
    June 4, 2012
    Date of Event
    April 27, 2012
    Report Date
    May 14, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    IKT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PER DEVICE HISTORY REPORT (DHR) REVIEW, INVESTIGATION DID NOT SHOW ISSUES RELATED TO THIS COMPLAINT. ASSESSMENT WAS CONDUCTED AND NO CHANGES REQUIRED. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, HOWEVER, WE WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: AS REPORTED BY THE COMPLAINANT UNABLE TO REMOVE PROTECTIVE COVER FROM THE NEEDLE POINT CAUTERY TO CONTROL THE BLEEDING. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK DISP. IMA/ENT 3/4" NEEDLE ELECTRODE NEEDLE ELECTRODE IKT TELEFLEX MEDICAL 01E1000136

    Patients

    Seq Age Sex Outcome Treatment
    1