ICE BAG, LARGE, W/ TIES, 6.5X14IN

Additional Manufacturer Narrative

THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. NO TREND WAS IDENTIFIED FOR THIS PRODUCT CATALOG NUMBER AND REPORTED ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED. THE INSTRUCTIONS FOR USE(IFU) FOR THE PRODUCT REPORTED CATALOG NUMBER 11400-100 STATES TO: ¿FILL THE ICE BAG WITH ICE/COLD WATER, OR COLD WATER ONLY. MAY RESULT IN CROSS INFECTION/CONTAMINATION IF USED ON MULTIPLE PATIENTS. IF THE BAG IS WORN UNDERNEATH THE BODY, SUCH AS UNDER A THIGH, THE MIDDLE-LAYER OF THE BAG WILL ABSORB ANY LEAKAGE AROUND THE NECK OF THE BAG AS THE ICE MELTS. IF A WET MIDDLE-LAYER OF THE BAG IS OBSERVED, DISCARD THE ICE BAG, AND USE A NEW ONE FOR ADDITIONAL THERAPY. NOT MADE WITH NATURAL RUBBER LATEX.¿ CARDINAL HEALTH WILL CONTINUE TO MONITOR AND TREND ALL SIMILAR REPORTED PRODUCT RELATED ISSUES.

Description of Event or Problem

PLAINTIFF (B)(6) ALLEGES THAT SHE WAS A PATIENT AT (B)(6) MEDICAL CENTER IN (B)(6). WHILE A PATIENT, SHE FELL WHILE USING THE BATHROOM AND SUBSEQUENTLY COMPLAINED OF PAIN IN HER BUTTOCKS AND RIGHT SHOULDER. WHILE SHE WAS WAITING FOR IMAGING TO ASSESS INJURIES IN CONNECTION WITH HER FALL, A NURSE BROUGHT A ¿HEAT PACK¿ TO PLAINTIFF. PLAINTIFF COMPLAINED THAT THE HEAT PACK WAS TOO HOT. THE NURSE RETURNED WITH ANOTHER HEAT PACK. WHEN THE NURSE ATTEMPTED TO PLACE THE SECOND HEAT PACK AT OR NEAR PLAINTIFF¿S INJURY, THE HEAT PACK ¿RUPTURED, CAUSING HEATED WATER TO COME INTO CONTACT WITH¿ PLAINTIFF¿S SKIN AND CAUSING SECOND- AND THIRD-DEGREE BURNS.