BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYHESIVE RETURN ELECTRODE

    MDR report key: 3944664 · Received May 5, 2014

    Report

    Report Number
    1717344-2014-00396
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 9, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT BURN OCCURRED. THE SITE HAS NOT PROVIDED ANY ADD'L INFO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268076 POLYHESIVE RETURN ELECTRODE PT RETURN ELECTRODE GEI COVIDIEN LP 32980159X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK