BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE IMA/ENT 3/4" NEEDLE ELECTRODE

    MDR report key: 2211934 · Received August 10, 2011

    Report

    Report Number
    3003898360-2011-00343
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 2, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    IKT
    Removal / Correction Number
    A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT BEEN RETURNED TO MANUFACTURER IN TIME FOR THIS REPORT. INVESTIGATION IS INCOMPLETE. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT WHEN THE DEVICE WAS TURNED ON, THE ELECTRODE OVERHEATED AND THE PLASTIC BELOW THE TIP MELTED. THIS HAPPENED BEFORE PT USE. UPON CLOSER EXAMINATION THE NEEDLE TIP HAD A BARB ON IT THAT SHOULD NOT BE THERE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE IMA/ENT 3/4" NEEDLE ELECTRODE NEEDLE ELECTRODE IKT TELEFLEX MEDICAL NA 01A1100150

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK