BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYHESIVE II RETURN ELECTRODE

    MDR report key: 2963001 · Received January 23, 2013

    Report

    Report Number
    1717344-2013-00040
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 2, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVAL. IF THE SAMPLE IS REC'D OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE BURNED A PT. THE DEGREE OF BURN AND TYPE OF TREATMENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33081 POLYHESIVE II RETURN ELECTRODE ES REM GROUNDING PAD GEI COVIDIEN LP 225656X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK