BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERATHERM MOIST HEAT 14X27 STD

    MDR report key: 1190045 · Received September 24, 2008

    Report

    Report Number
    1022819-2008-00261
    Event Type
    Injury
    Date Received
    September 24, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDER EVAL. THE DEVICE EVAL AND ANY ADDITIONAL FINDINGS WILL BE PROVIDED UPON CONCLUSION OF THE DEVICE EVAL.

    Description of Event or Problem · 1

    THE PT WAS USING THE DEVICE WHEN THE DEVICE UNEXPECTEDLY BEGAN TO OVERHEAT. THE PT IMMEDIATELY STOPPED USE OF THE DEVICE. THE PT DID NOT CONTINUE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERATHERM MOIST HEAT 14X27 STD IRT CHATTANOOGA GROUP 1032

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention