BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOTEX

    MDR report key: 1151677 · Received September 4, 2008

    Report

    Report Number
    1528424-2008-00007
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    March 28, 2007
    Report Date
    September 4, 2008
    Manufacturer
    THERMOTEX THERAPY SYSTEM LTD.
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    (B) (6) COMPLAINED THAT THE TERMOTEX HEATING PAD CAUSED INJURIES REQUIRING MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOTEX HEATING PAD IRT THERMOTEX THERAPY SYSTEM LTD. PLATINUM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O