UNKNOWN COLD PACK

Additional Manufacturer Narrative

UNFORTUNATELY, NO LOT NUMBER WAS PROVIDED SO THE DHR (DEVICE HISTORY RECORD) COULD NOT BE REVIEWED. THE PRODUCT SAMPLE REPORTEDLY WAS AVAILABLE BUT WAS NOT RECEIVED FROM THE CUSTOMER. CONSEQUENTLY, WE WERE UNABLE TO DETERMINE THE ROOT CAUSE OF THE PROBLEM REPORTED. UNDER ROUTINE 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. IT IS VITAL TO THE INVESTIGATION THAT THE PRODUCT SAMPLE BE AVAILABLE FOR EXAMINATION AND TESTING IN ORDER TO DETERMINE THE ROOT CAUSE. UNFORTUNATELY, NO SAMPLES WERE PROVIDED, SO THE EXACT CAUSE OF THE DIFFICULTIES ENCOUNTERED CANNOT BE CONFIRMED. IN ADDITION, THE COMPLAINANT STATES THAT SHE DID NOT FOLLOW THE INSTRUCTIONS AS STATED ON THE PACK FOR EITHER THE DURATION OF THERAPY OR FOR THE DIRECT PLACEMENT ON SKIN.

Description of Event or Problem

REPORTER SAID THAT IT WAS A VERY OLD GEL PACK WHICH SHE BORROWED FROM A FRIEND. SHE SAID, SHE TOOK IT OUT OF THE FREEZER AND APPLIED IT DIRECTLY TO HER BACK, INSTEAD OF WRAPPING IT LIKE THE INSTRUCTIONS SAY, BUT SHE SAID SHE HAS NEVER WRAPPED PACKS BEFORE APPLYING THEM TO HER SKIN AND HAS NOT HAD A PROBLEM. SHE SAID IT WASN'T "SUPER COLD" AND THAT IT FELT OKAY WHEN SHE PUT IT ON, BUT LATER IN THE NIGHT IT SOMEHOW PUNCTURED AND LEAKED ONTO HER SKIN, WHICH SHE NOTICED BECAUSE OF THE BLUE ON HER CLOTHING. SHE CHANGED HER CLOTHES, BUT DID NOT WAS HER SKIN. WHEN SHE WOKE UP, SHE SAID THAT HER BACK WAS RED, HOT TO TOUCH, AND BURNING. SHE SAID, SHE THOUGHT IT WAS MORE LIKE A CHEMICAL BURN THAN A FREEZER BURN. SHE SAID SHE WENT TO HER DOCTOR, AND HER DOCTOR WASN'T SURE WHAT IT WAS, AND THOUGHT IT MIGHT BE THE SHINGLES. SHE SAID THAT PEOPLE SHE HAD TALKED TO SAID IT LOOKED MORE LIKE A CHEMICAL BURN TO HER. SHE SAID THE MAIN THING SHE IS WORRIED ABOUT IS WHAT CHEMICAL WAS TOUCHING HER SKIN, AND SHE WANTS TO KNOW WHAT HER CHEMICAL EXPOSURE IS.