BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOPHORE

    MDR report key: 6665713 · Received June 23, 2017

    Report

    Report Number
    1832415-2017-05842
    Event Type
    Injury
    Date Received
    June 23, 2017
    Date of Event
    June 1, 2016
    Report Date
    June 19, 2017
    Manufacturer
    BATTLE CREEK EQUIPMENT CO.
    Product Code
    IRT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HOLDING THE SWITCH AND BURNED HIS HAND. IT TURNED BLACK AND CAUSED A BLISTER. THE PRODUCT WAS SENT BACK FOR INVESTIGATION, THE QUALITY INSPECTOR OBSERVED A CORD CUT OR BURNED STRAIN RELIEF ON THE PRODUCT. THE PAD IN QUESTION WAS MANUFACTURED ON 7/18/2003. THE PRODUCT WAS APPROX. 13 YEARS OLD WHEN THE INCIDENT OCCURED. THE PRODUCT HAS A LIFECYCLE OF 4 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445864 THERMOPHORE THERMOPHORE CLASSIC IRT BATTLE CREEK EQUIPMENT CO. 055 031990

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention