BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE ELECTRODE

    MDR report key: 3945244 · Received May 5, 2014

    Report

    Report Number
    1717344-2014-00394
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 18, 2014
    Report Date
    April 7, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    JOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE COAGULATING, A FLAME WAS NOTICED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO INJURIES TO THE PT. THE SITE REPORTED THAT BETADINE ALCOHOL HAD BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268081 NEEDLE ELECTRODE ES ACCESSORY JOS COVIDIEN LP 33100155X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK