BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPERSIVE ELECTRODE (TIN/KATECHO)

    MDR report key: 2509468 · Received March 26, 2012

    Report

    Report Number
    1056436-2012-00027
    Event Type
    Other
    Date Received
    March 26, 2012
    Date of Event
    March 6, 2012
    Report Date
    March 20, 2012
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO: MODEL 1500X RF GENERATOR; RFA GENERATOR; CATALOG #: 700-10173; LOT #: A041461.

    Description of Event or Problem · 1

    NOT SURE IF DEVICE FAILED, BUT PT SUFFERED A PAD BURN UNDER ONE OF THE TWO GROUNDING PADS USED. INFO RECEIVED FROM SALES REP. ON (B)(4) 2012: BELIEVE ONE PAD WAS NOT PLUGGED IN COMPLETELY. PT WAS SMALL, PRONE, PLACED PADS ON SCAPULA, OVERLAPPED PADS. ONE THIRD OF PAD ON SKIN-RT SIDE, OTHER COMPLETE CONTACT WITH SKIN ON PT LFT. TREATMENT WAS ON LEFT SACRAL MASS. COUPLE MINUTES (3 MINS) INTO ABLATION PADS NOTICED NOT COMPLETELY PLUGGED IN. CASE WENT FINE-COOL TEMPS GOOD, UNDER PADS FINE WITH LEAST EXPOSURE HAD BURN ON LEADING EDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPERSIVE ELECTRODE (TIN/KATECHO) RFA ELECTRODE GEI ANGIODYNAMICS, INC. NA Y101411-03

    Patients

    Seq Age Sex Outcome Treatment
    1 Other