BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI PWR DISPOSBL GRNDING PAD

    MDR report key: 2112881 · Received May 24, 2011

    Report

    Report Number
    1717344-2011-00393
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 24, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT FOLLOWING AN ABLATION PROCEDURE WHEN THE PAD WAS REMOVED, IT WAS NOTICED THERE WAS A BURN ON THE PT'S LEFT THIGH WHERE PAD HAD BEEN APPLIED. THE PAD WAS APPLIED ON THE PT'S THIGH LENGTHWISE WITH THE CABLE SIDE CLOSE TO THE KNEE. THE BURN OCCURRED AT THE BOTTOM PART OF THE PAD (FAR FROM THE CABLE). DEGREE OF BURN IS UNK. THE PT IS UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI PWR DISPOSBL GRNDING PAD RF ABLATION GROUNDING PAD GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CTRF100 ABLATION GENERATOR, S/N UNK| ACT2030 NEEDLE ELECTRODE, LOT # UNK