THERMOTEX THERAPY SYSTEMS

Description of Event or Problem

(B)(6) CONTACTED US TO SAY HE HAD USED HIS TTS PLATINUM PAD FOR ABOUT 20 MINUTES. HE SAID IT DID NOT FEEL HOT AT THE TIME OF USE, BUT LATER THAT NIGHT OR THE NEXT MORNING, HIS WIFE NOTICED A BLISTER ABOUT THE SIZE OF A 50 CENT PIECE. HE ASKED IF WE WOULD SEND HIM A REPLACEMENT HEATING PAD. (B)(6) SUFFERS FROM SCIATICA AND WAS TREATING PAIN THAT RADIATES DOWN TO HIS LOWER LEG. HE WAS TREATING THE LOWER PORTION OF HIS LEFT LEG. THE BLISTER APPEARED ON THE OUTSIDE OF HIS LEG APPROXIMATELY 8" ABOVE HIS ANKLE. HE DID GO TO HIS DOCTOR TO GET AN OINTMENT TO TREAT IT. THE MEDICAL RECORDS WERE NOT SUPPLIED.

Additional Manufacturer Narrative

PHYSICAL INSPECTION OF THE RETURNED TTS PLATINUM SHOWED NO UNUSUAL WEAR ON THE OUTER COVER AND EACH HEAT INSERT APPEARED TO BE IN GOOD CONDITION. SEVERAL TESTS WERE PERFORMED MEASURING THE TEMPERATURES OF EACH HEAT INSERT OVER A PERIOD OF TIME USING A FLUKE 54 II THERMOMETER. IN ONE PARTICULAR TEST THAT WAS PERFORMED ON EACH HEAT INSERT, TEMPERATURES WERE MEASURED AT ONE MINUTE INTERVALS FOR 499 MINUTES, THE HEAT INSERTS WERE SET AT THE HIGH SETTING. THIS SAME TEST WAS PERFORMED WITH THE HEAT INSERTS SET ON THE LOW SETTING. TEMPERATURES FOR BOTH TESTS (HIGH AND LOW SETTINGS) WERE FOUND TO BE WELL WITHIN SET PARAMETERS. ANOTHER SERIES OF TESTS WERE PERFORMED MEASURING THE TEMPERATURES (IN ONE MINUTE INTERVALS) OVER A PERIOD OF 20 MINUTES ON THE HIGH SETTING JUST AS BB DESCRIBED HE USED THE PRODUCT BEFORE THE ADVERSE EVENT OCCURRED. THE MAXIMUM TEMPERATURE REACHED DURING THIS TIME PERIOD WAS 53 DEGREES CELSIUS WITH THE AVERAGE TEMPERATURE OVER THE 20 MINUTE PERIOD BEING 41.78 DEGREES CELSIUS. IN CONCLUSION, THE TTS PLATINUM WAS FOUND TO BE WORKING WITHIN SPECIFICATIONS, NO FAILURES WERE DETECTED.