UNKNOWN COLD PACK

Description of Event or Problem

SHE SAID, SHE HAD RECEIVED THE GEL PACK FROM SOMEONE ELSE. SHE SAID, THE PACK WAS FROZEN, AND SHE PLACED IT IN A TOWEL AND THEN PLACED IT ON HER BACK AND LAY DOWN. SHE SAID, THAT IS WAS ON HER BACK FOR LESS THAN 10 MINUTES AND SHE NOTICED IT WAS REALLY COLD, SO SHE TOOK IT OFF HER BACK. THAT IS WHEN SHE SAID THAT SHE NOTICED A BURN ON HER BACK. SHE WENT TO THE DOCTOR, AND SAID THAT BY THIS TIME, THERE WAS BLISTER FORMING AND THE BURNED AREA WAS 5 1/2"X6: IN DIAMETER.

Additional Manufacturer Narrative

AS NO SAMPLES WERE PROVIDED TO DATE, THE EXACT CAUSE OF THE DIFFICULTIES ENCOUNTERED CANNOT BE DETERMINED. IN ADDITION, NO LOT NUMBER WAS REPORTED, SO THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. UNDER ROUTING PRODUCTION, A SAMPLING OF THESE UNITS IS TESTED FOR POUCH INTEGRITY AND THE PRODUCTION RUN IS NOT RELEASED UNTIL ALL ASPECTS OF PRODUCT QUALITY MEET PRODUCT SPECIFICATIONS. ALTHOUGH GREAT EFFORT IS TAKEN IN ENSURING THAT ALL FUNCTION AS DESIGNED, AT TIMES, ONE MAY FAIL TO MEET PERFORMANCE EXPECTATIONS FOR A CERTAIN REASON. IN THOSE INSTANCES, IT IS VITAL TO THE INVESTIGATION THAT THE PRODUCT SAMPLE BE AVAILABLE FOR EXAMINATION AND TESTING IN ORDER TO DETERMINE THE ROOT CAUSE. UNFORTUNATELY, IN THIS SITUATION THAT IS NOT THE CASE. WE WILL CONTINUE TO MONITOR FOR OTHER SIMILAR COMPLAINTS AND UTILIZE THE INFORMATION AS PART OF CONTINUOUS IMPROVEMENT.