BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOTEX

    MDR report key: 1356284 · Received April 3, 2009

    Report

    Report Number
    1528424-2009-00002
    Event Type
    Injury
    Date Received
    April 3, 2009
    Date of Event
    December 1, 2008
    Report Date
    April 3, 2009
    Manufacturer
    THERMOTEX THERAPY SYSTEMS LTD.
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    (B) (6) CONTACTED OUR CUSTOMER SERVICE ON 04/01/09 AND STATED THAT SHE HAD RECEIVED A 2ND DEGREE BURN ON HER HIP FROM THE UNIT WHILE USING IT IN (B) (6) 2008. WHEN CALLED ON (B) (6), SHE STATED THAT SHE HAD THE UNIT NEXT TO HER SKIN AND HAD FALLEN ASLEEP ON THE PAD SHE DID NOT KNOW FOR HOW LONG. (B) (6) HAD BEEN PREVIOUSLY HOSPITALIZED FOR A FALL INJURY, SHE WAS REHABILITATING AT HOME UNDER THE CARE OF HOME HEALTH AIDES WHEN THE INCIDENT HAPPENED. IT WAS THE AIDE THAT NOTICED HER HALF DOLLAR SIZE WOUND, SHE INFORMED THE NURSE THAT VISITED AND SHE WAS UNABLE TO DRESS AND CARE FOR THE WOUND WITHOUT FURTHER MEDICAL INTERVENTION. AS OF (B) (6) WHEN WE SPOKE, (B) (6) WAS DOING MUCH BETTER, SHE WAS NOT ABLE TO NOTIFY US ABOUT HER BURN PREVIOUS TO THIS DATE DUE THE FACT THAT HER FALL INJURY HAD LEFT HER UNABLE TO DO SO. (B) (6) WOULD NOT RETURN THE UNIT TO BE EVALUATED AS SHE LOVES THE UNIT AND WANTS TO CONTINUE TO USE IT TO RELIEVE HER PAIN. SHE INDICATED SHE WOULD BE MORE CAREFUL USING IT IN THE FUTURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other