BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYHESIVE II RETURN ELECTRODE

    MDR report key: 3240566 · Received July 16, 2013

    Report

    Report Number
    1717344-2013-00523
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    March 27, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PATIENT RECEIVED 1ST-2ND DEGREE BURNS ON THE INGUINAL REGION DURING HEART SURGERY. THE PATIENT GROUNDING PAD WAS PLACED ON PATIENT'S BACK. THE SITE COULD NOT FIND ANY PROBLEM WITH THE ELECTROSURGICAL GENERATOR. NO PROBLEM WAS EXPERIENCED DURING THE PROCEDURE. THE SITE HAS NOT PROVIDED ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330214 POLYHESIVE II RETURN ELECTRODE PATIENT GROUNDING PAD GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK