BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE ELECTRODE 3/8"

    MDR report key: 1786632 · Received June 21, 2010

    Report

    Report Number
    1044475-2010-00069
    Event Type
    Malfunction
    Date Received
    June 21, 2010
    Date of Event
    January 25, 2010
    Report Date
    May 25, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GXZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS SENT TO THE MFG SITE FOR EVAL. THE RESULTS OF THE EVAL ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS DESCRIBED AS: DURING A PROCEDURE THE NEEDLE TIP MELTED UPON ACTIVATION OF DIATHERMY MACHINE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEEDLE ELECTRODE 3/8" NEEDLE ELECTRODE GXZ TELEFLEX MEDICAL NA 04A0800007

    Patients

    Seq Age Sex Outcome Treatment
    1