BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMOPAD

    MDR report key: 1591186 · Received January 26, 2010

    Report

    Report Number
    1056436-2009-00091
    Event Type
    Other
    Date Received
    January 26, 2010
    Date of Event
    October 2, 2009
    Report Date
    January 25, 2010
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BLUE THERMOPADS WERE USED. ICE PACKS WERE APPLIED BY THE STAFF BUT MUST HAVE MISSED THE INTERIOR LEADING EDGE OF THE PAD WHERE THE BURN WAS LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOPAD RFA PAD GEI ANGIODYNAMICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other