BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RFA GROUNDING PAD

    MDR report key: 3031290 · Received March 5, 2013

    Report

    Report Number
    1717344-2013-00160
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 8, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE WAS DISCARDED AT THE SITE AND IS NOT AVAILABLE FOR EVALUATION. 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 THE PT RECEIVED A 2ND DEGREE BURN AT THE RETURN PAD SITE ON THE UPPER RIGHT LEG. THE BURN WAS NOTED AFTER THE PROCEDURE WHEN THE PAD WAS REMOVED. THE INCIDENT PAD WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. TREATMENT INFO IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94750 RFA GROUNDING PAD RF ABLATION GROUNDING PAD GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK (B)(4) ELECTRODE, L/N 238473X| (B)(4) ELECTRODE, L/N UNKNOWN