BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLYHESIVE II RETURN ELECTRODE

    MDR report key: 1153543 · Received August 6, 2008

    Report

    Report Number
    1153543
    Event Type
    Other
    Date Received
    August 6, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 6, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    ODR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE MEDWATCH REPORT FROM THE CUSTOMER, THE PT UNDERWENT A RADIO FREQUENCY ABLATION OF A HEPATIC TUMOR. UPON ARRIVAL TO FLOOR, POSTOPERATIVELY, THE PT WAS NOTED WITH A 4.5 CM OPEN CIRCULAR SHAPE VESICULAR AREA TO RIGHT SIDE OF THE BACK / FLANK. THE RISK MGR WAS CONTACTED AND INDICATED THE INJURY WAS A 'SIGNIFICANT' BURN THAT OCCURRED AT THE PAD SITE. THE INCIDENT PAD WAS DISCARDED. THE RISK MGR WOULD NOT DISCLOSE ANY ADD'L INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYHESIVE II RETURN ELECTRODE ELECTROSURGICAL ACCESSORY ODR COVIDIEN LP (VALLEYLAB) * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other