CVS (PRIVATE LABEL)

Description of Event or Problem

CUSTOMER STATES THAT THIS PRODUCT HAS GIVEN HER 2ND DEGREE BURNS AND ALSO SHE HAS MISSED OUT OF WORK. SHE HAD BEEN WORKING OUT AND WAS SWEATING. SHE HAS HAD THE COLD PACK FOR SEVERAL MONTHS AND HAD IT IN HER FREEZER. ONCE SHE WAS DONE WORKING OUT, SHE WRAPPED A TOWEL AROUND THE COLD PACK AND PUT IT ON HER BACK. SHE STARTED TO FEEL BURNING ON HER BACK THAT NIGHT AND WAS IN SO MUCH PAIN THE NEXT DAY THAT SHE WENT TO URGENT CARE WHO SENT HER TO THE EMERGENCY ROOM. THE EMERGENCY ROOM DOCTOR SAID THAT THE LIQUID WAS LEAKING OUT OF A SEAM AND WAS BLISTERING HER BACK. HE SAID THAT IT APPEARED THAT SHE WAS HAVING AN ALLERGIC REACTION TO WHAT WAS INSIDE THE PACK. HE DISPOSED OF THE PACK SO SHE DOESN'T HAVE IT TO SEND BACK TO US. SHE MISSED A DAY OF WORK FOR THE AMOUNT OF (B)(6). SHE HAS HAD TO PAY OUT A CO-PAY OF (B)(6) AND ONE OF (B)(6). PLUS SHE HAS TO GO BACK TO THE DOCTOR'S TOMORROW. HE WANTS HER TO SEE A WOUND DOCTOR ABOUT THE BURNS. SHE HAS TO HAVE SOMEBODY DRIVE HER PLACES AS SHE CAN'T LEAN HER BACK AGAINST THE SEAT. INSTRUCTIONS/BOX ARTWORK ATTACHED: INSTRUCTIONS/BOX ARTWORK ATTACHED. INSTRUCTIONS FOR USE: #2: REMOVE COMPRESS FROM FREEZER AND PLACE INTO PROTECTIVE WRAP. CHECK FOR DESIRED TEMPERATURE. IF TEMPERATURE IS ACCEPTABLE, APPLY THE COMPRESS TO THE AFFECTED AREA. #3: NOTE: AS FREEZER TEMPERATURES VARY, MONITOR THE SKIN PERIODICALLY DURING APPLICATION TO AVOID FROSTBITE. COMPRESS MAY NEED TO BE WRAPPED IN A TOWEL OR CLOTH FOR APPLICATION TO SENSITIVE AREAS. STOP USE IF THE TEMPERATURE BECOMES UNCOMFORATABLE OR IF THE SKIN BECOMES BRIGHT PINK OR RED. #4: APPLY FOR A MAXIMUM OF 15-20 MINUTES. WAIT 1 HOUR BETWEEN SESSIONS, OR AS DIRECTED BY A HEALTHCARE PROVIDER. CAUTION/WARNING: DO NOT USE THE COMPRESS WITHOUT THE PROTECTIVE WRAP. DO NOT SIT OR LAY ON THE COMPRESS. DOING SO MAY INCREASE RISK OF TEMPERATURE-RELATED INJURY, AND MAY CAUSE THE DEVICE TO LEAK. DO NOT USE WHILE SLEEPING OR UNDER THE INFLUENCE OF MIND-ALTERING DRUGS, ALCOHOL, OR WHILE SUFFERING FROM DIZZINESS. IN THE EVENT OF A LEAK, DISPOSE OF PRODUCT AND CLEAN ANY GEL OFF OF SKIN WITH SOAP AND WATER. THE LIKELY ROOT CAUSE OF THIS EVENT WAS DETERMINED TO BE USER ERROR BECAUSE IF THE DEVICE WAS IS IN IT'S PROTECTIVE WRAP AND WRAPPED IN A TOWEL IT WOULD NOT HAVE LEAKED ONTO THE END-USER'S SKIN. SHE STATED SHE TOOK THE DEVICE OUT OF THE FREEZER THEN WRAPPED IT IN A TOWEL, NEVER STATED IF SHE PUT IT INTO THE PROTECTIVE WRAP FIRST. THE END-USER NEVER STATED THE DEVICE WAS LEAKING, ONLY THAT THE DOCTOR SAID IT LEAKED DOWN HER BACK; BUT IF THAT WERE SO THERE WOULD HAVE BEEN CONTENT ON THE END-USERS CLOTHES, WRAP, AND TOWEL WHICH THE END-USER NEVER STATED HAPPENED. IT IS ALSO VERY LIKELY THE END-USER DID NOT FOLLOW THE INSTRUCTIONS THAT THE WRAP WAS NOT TO BE APPLIED FOR MORE THAN 15-20 MINUTES AT A TIME. BASED ON THE PICTURE PROVIDED AS TO THE LOCATION OF BURN, MIDDLE OF BACK, THE END-USER HAD TO HAVE LEANED OR LAID ON THE DEVICE IN ORDER FOR IT TO REMAIN IN PLACE.