BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOTEX

    MDR report key: 1275062 · Received December 22, 2008

    Report

    Report Number
    9615330-2008-00001
    Event Type
    Injury
    Date Received
    December 22, 2008
    Date of Event
    February 1, 2007
    Report Date
    February 5, 2007
    Manufacturer
    THERMOTEX THERAPY SYSTEMS LTD.
    Product Code
    ILY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER EXPLAINED HOW SHE WAS USING THE DEVICE WHEN THE EVENT OCCURRED. SHE WAS AWARE SHE WAS USING IT INCORRECTLY. SHE STATED SHE KNEW SHE WAS NOT TO USE THE HIGH SETTING FOR MORE THAN 10-15 MINUTES, AND SHE KNEW SHE WAS NOT SUPPOSED TO SLEEP WITH IT ON.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO SEE HOW SHE SHOULD TREAT A COUPLE OF BLISTERS SHE GOT FROM USING HER THERMOTEX TTS PLATINUM PAD. SHE SAID SHE HAD A HOT BATH, AND WENT TO BED LAYING ON HER TTS PLATINUM PAD. SHE HAD THE SWITCH SET TO THE HIGH SETTING AND FELL ASLEEP ON IT FOR 8 HOURS. REP ADVISED HER TO SEE HER DOCTOR FOR TREATMENT. CUSTOMER SAID SHE KNEW THAT SHE WAS ONLY SUPPOSED TO HAVE IT ON THE HIGH SETTING FOR ABOUT 10 MINUTES AND THAT THE INSTRUCTIONS SAID NOT TO SLEEP ON IT. IN 2007, REP CALLED THE CUSTOMER TO FOLLOW UP ON HOW SHE WAS FEELING. SHE HAD BEEN TO A CLINIC TO SEE A DOCTOR AND RECEIVED TREATMENT FOR HER BLISTERS. I ASKED HER TO SEND US A NOTE IN HER WORDS, DETAILING THE EVENT. (SHE DID NOT SEND US ANYTHING). SHE DID ASK ME WHEN I FELT SHE COULD START USING HER THERMOTEX PAD AGAIN BECAUSE IT REALLY HELPS HER BACK (SHE HAS CURVATURE OF THE SPINE). I ADVISED HER NOT TO USE IT AGAIN UNTIL SHE HAS HEALED AND IS NO LONGER USING SALVES ON HER BLISTERS. I ALSO REMINDED HER NOT TO USE THE HIGH SETTING FOR MORE THAN 10-15 MINUTES (TO BRING THE TTS PLATINUM UP TO TEMPERATURE QUICKLY) AND THEN TO USE IT ON THE LOW SETTING AND TO NOT SLEEP WITH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOTEX THERMOTEX THERAPY SYSTEMS ILY THERMOTEX THERAPY SYSTEMS LTD. TTS PLATINUM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other