BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYHESIVE RETURN ELECTRODE

    MDR report key: 4132898 · Received October 1, 2014

    Report

    Report Number
    1717344-2014-00864
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 17, 2014
    Manufacturer
    COVIDIE LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 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 THAT A PATIENT HAD UNDERGONE A RENAL RFA PROCEDURE WITHOUT ANY COMPLICATIONS. THE PATIENT, UPON BEING DISCHARGED HOME, NOTICED SOME BLISTERS ON THE TOP OF HER THIGH. THE NURSING STAFF DID NOT NOTICE ANY BLISTERS ON HER THIGH UPON REMOVAL OF THE GROUNDING PAD IMMEDIATELY AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612320 POLYHESIVE RETURN ELECTRODE PATIENT RETURN ELECTRODE GEI COVIDIE LP E7506

    Patients

    Seq Age Sex Outcome Treatment
    1