BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK DISPOSABLE ELECTRODE IMA/ENT

    MDR report key: 1080278 · Received July 22, 2008

    Report

    Report Number
    3003898360-2008-00062
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    May 9, 2008
    Report Date
    July 3, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL REPORT NOT AVAILABLE AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDWATCH REPORT WAS RECEIVED FROM CUSTOMER STATING THAT THE DOCTOR WAS USING THE CAUTERY IN SURGERY AND THE BLADE SPARKED. NO PT INJURY OR INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK DISPOSABLE ELECTRODE IMA/ENT DISPOSABLE ELECTRODE GEI TELEFLEX MEDICAL 01L0700066

    Patients

    Seq Age Sex Outcome Treatment
    1