BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RFA GROUNDING PAD

    MDR report key: 3221666 · Received July 1, 2013

    Report

    Report Number
    1717344-2013-00483
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 6, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE #: (B)(4). DATE OF INITIAL REPORT: (B)(4) 2013. THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVAL. 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 DURING AN ABLATION PROCEDURE, THE PT COMPLAINED THAT THE AREA ADJACENT TO THE GROUNDING PAD SITE WAS HOT. THE AREA WAS CHECKED AND PROBLEM WAS NOTED. AFTER THE PROCEDURE THE STAFF OBSERVED A 1 CM X 2 CM RED AREA WHERE THE PAD WAS ATTACHED. TWO DAYS AFTER THE PROCEDURE, THEY CONFIRMED THE AREA WAS CLEAR. THE CUSTOMER DOES NOT KNOW IF THE INJURY WAS A BURN OR RASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297355 RFA GROUNDING PAD ABLATION GROUNDING PAD GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK