BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RFA GROUNDING PAD

    MDR report key: 3170789 · Received May 22, 2013

    Report

    Report Number
    1717344-2013-00370
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 26, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    ODR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE WAS DISCARDED BY THE SITE AND IS NOT AVAILABLE FOR EVAL. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. 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 FOLLOWING AN ABLATION PROCEDURE, THE PT COMPLAINED OF PAIN ON THE LEFT THIGH. A 2ND DEGREE BLISTER WAS NOTED AT THE PAD SITE. THE BLISTER WAS SUCTIONED AND THE TP STATUS WAS GOOD. THE INCIDENT PAD WAS DISCARDED BY THE CUSTOMER FOLLOWING THE PROCEDURE AND IS NOT AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227322 RFA GROUNDING PAD RF ABLATION GROUNDING PAD ODR COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR RFA2030 ELECTRODE: LOT # UNK| RFAGENJ ABLATION GENERATOR: S/N (B)(4)