BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WECK/TELEFLEX MEDICAL NEEDLE ELECTRODE

    MDR report key: 3193504 · Received June 20, 2013

    Report

    Report Number
    MW5030669
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    WECK/TELEFLEX MEDICAL
    Product Code
    GXZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE COURSE OF TONSILLECTOMY SURGERY IT WAS NOTED THAT THE PT SUSTAINED A BURN TO THE INNER PORTION OF HIS LEFT CHEEK. IT WAS THEN IDENTIFIED THAT THE NEEDLE ELECTRODE HAD A BURN THROUGH THE INSULATION RESULTING IN A BURN TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281480 WECK/TELEFLEX MEDICAL NEEDLE ELECTRODE NEEDLE ELECTRODE GXZ WECK/TELEFLEX MEDICAL REF# 809337 01D1200333

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention VALLEYLAB ELECTROSURGICAL UNIT, FORCE FX MODEL