REUS COLD PK SM 5.5X7

Description of Event or Problem

PER CUSTOMER SHE PUT THE 'ICE PACK' ON HER SORE SHOULDER FOR 25 MINUTES. WHEN SHE REMOVED THE PACK SHE NOTICED A SIGNIFICANT CHANGE IN THE COLOR AND TEXTURE OF HER SHOULDER. IT FELT MUCH BETTER AS THERE WAS NO PAIN. THE NEXT MORNING SHE WOKE TO A MAJOR BURN ON HER SHOULDER TO INCLUDE VERY LARGE BLISTERS. SHE WENT TO WORK AND HAD A NURSE LOOK AT IT AND THE NURSE SAID THAT IT APPEARED TO BE A THIRD DEGREE BURN AND TO GO GET MEDICAL ATTENTION ASAP BECAUSE BURNS BECOME INFECTED VERY QUICKLY. SHE WENT TO THE URGENT CARE CLINIC AT CVS PHARMACY AND THEY WOULD NOT TREAT HER BECAUSE OF THE SEVERITY OF THE BURN SO SHE WENT TO THE ER. IT WAS CONFIRMED AT THE ER THAT IT WAS A SECOND DEGREE BURN FROM THE ICE PACK. COMPLETE CUSTOMER LETTERS ATTACHED.

Additional Manufacturer Narrative

TO DATE, THE SAMPLE HAS NOT BEEN RECEIVED BY THE FACILITY. THEREFORE, IT CANNOT BE DETERMINED AT THIS TIME WHAT THE CAUSE FOR THIS INCIDENT WAS. CUSTOMER STATES THE PRODUCT WAS NOT COMPROMISED IN ANY WAY. ALSO, THE CUSTOMER STATES THAT THE PRODUCT WAS ORIGINALLY ACTIVATED ON (B)(4), 2009 AND THEN RE-USED AGAIN ON (B)(4), 2009. THE CUSTOMER DOES NOT INDICATE WHERE THE PRODUCT WAS STORED UNTIL USE ON (B)(4), 2009. LABEL COPY CLEARLY STATES: TO RE-USE, PLACE PACK IN THE REFRIGERATOR FOR 15 MINUTES, INSULATION SIDE DOWN. DO NOT FREEZE. THE DHR FOR LOT V8N044 WAS INVESTIGATED. NO ISSUES WERE DOCUMENTED DURING MANUFACTURE. A REVIEW OF SIMILAR CODES FOR COMPLAINTS OF THIS TYPE REVEALED NO ADVERSE TRENDS.