THERMIPAQ

Description of Event or Problem

STATED THE DEVICE EXPLODED AND BURNED END USER. THE PLASTIC BAG EXPLODED AT THE SEAM ON THE BAG. SHE PUT THE WHOLE PRODUCT WITH THE PAD COVER ON INSIDE THE MICROWAVE FLAT ON THE GLASS TRAY (WITHOUT WATER). SHE HEATS IT FOR 5-6 SECONDS AT A TIME UNTIL IT FEELS WARM ENOUGH. SHE DIDN'T FEEL IT FIRST BUT WHEN SHE WENT TO TAKE IT OUT OF THE MICROWAVE, AS SOON AS SHE PULLED IT OUT OF THE MICROWAVE, IT EXPLODED. IT BUSTED AT THE VELCRO AND THE STEAM FROM THE PRESSURE IS WHAT GOT HER. IT HIT HER DOWN HER SHOULDER AND UP THE INSIDE OF HER ARM AND HER LEFT BREAST AND HER LEFT NIPPLE. SECOND DEGREE BURN ON HER BREAST PART AND FIRST DEGREE BURN ON HER ARM. HAPPENED LAST (B)(6) MONDAY AT 3:00 IN THE AFTERNOON. WENT TO THE DOCTOR AND THEY HAD TO KNOCK HER OUT 2 TIMES FOR TREATMENT. GOING TO GET SET UP WITH WOUND CARE TOO. SAID SHE'S HAD THIS PRODUCT SINCE (B)(6) 2021 FROM (B)(6). THE MICROWAVE IS 1100 WATTS. DEVICE WAS USED INCORRECTLY: INSTRUCTIONS ATTACHED. HEAT THERAPY: PLACE PAD IN ITS CLOTH COVER, FOLD IN HALF AND PLACE IN CENTER OF MICROWAVE. FIND THE POWER RATING OF YOUR MICROWAVE ON THE BELOW CHART. SET THE POWER TO HIGH FOR THE TIME INDICATED. DO NOT APPLY THE INNER PACK DIRECTLY TO THE SKIN. ALWAYS USE THE CLOTH COVER. THE HEATING TIMES ARE AS FOLLOWS: 600 WATT 1 MIN. 30 SEC., 800 WATT 1 MIN. 15 SEC., 1000 WATT 1 MIN., 1200 WATT 45 SEC. IMPORTANT: DO NOT EXCEED HEATING TIMES. OVERHEATING WILL DAMAGE THE PAD AND VOID THE WARRANTY. WHILE IN THE MICROWAVE, IF THE PAD BEGINS TO UNFOLD OR IF ANY SWELLING OF THE PAD IS OBSERVED, THEN IMMEDIATELY TURN OFF THE MICROWAVE. WAIT FOR THE SWELLING TO GO DOWN BEFORE OPENING THE MICROWAVE DOOR. IMPORTANT: DUE TO ITS RADIANT ENERGY, THE THERMIPAQ WRAP WILL NORMALLY CONTINUE HEATING FOR UP TO 3 MINUTES AFTER YOU REMOVE IT FROM THE MICROWAVE. IF A HOTTER TEMPERATURE IS DESIRED AFTER 3 MINUTES HAVE ELAPSED, HEAT THE PAD IN THE MICROWAVE FOR 15 SECONDS AT A HIGH SETTING AND TEST IT AGAIN. REPEAT THIS PROCESS UNTIL A DESIRED TEMPERATURE IS REACHED. **THE END-USER CONTINUED TO HEAT THE DEVICE UNTIL SHE FELT IT WAS "WARM ENOUGH", NOT FOLLOWING THE HEATING INSTRUCTIONS FOR HER WATTAGE OF MICROWAVE. ALSO, SHE LAID THE DEVICE FLAT IN THE MICROWAVE WHEN THE INSTRUCTIONS STATE TO FOLD THE DEVICE; WHEN FOLDED IF IT STARTS OVERHEATING IT WILL EXPAND AND UNFOLD THE DEVICE ALERTING THE END-USER TO TURN OFF THE MICROWAVE AND WAIT ON IT TO DEFLATE (PER INSTRUCTIONS).