BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI PWR DISPOSBL GRNDING PAD

    MDR report key: 2190347 · Received July 20, 2011

    Report

    Report Number
    1717344-2011-00577
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 12, 2011
    Report Date
    June 24, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 EVAL. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED, OR 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 ON (B)(6), THE SURGEON NOTED SOME 3RD DEGREE BURNS ON THE INSIDE OF THE LEFT THIGH OF THE PT (WHERE THE PT RETURN ELECTRODE HAD BEEN PLACED). THE CUSTOMER HAS NOT PROVIDED ANY ADD'L INFO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other CTRF220 ABLATION GENERATOR, S/N (B)(4)