3M (TM) ACE (TM) HOT AND COLD COMPRESS WITH SLEEVE

Additional Manufacturer Narrative

HOT AND COLD COMPRESS PRODUCT LABELING STATES: MICROWAVE HEATING: LAY PACK FLAT IN THE MICROWAVE OVEN ON A PAPER TOWEL OR PAPER PLATE; HEAT AT FULL POWER FOR 20 SECONDS. IF PACK EXPANDS LIKE A BALLOON: STOP HEATING. PACK IS TOO HOT. LET PACK COOL. CHECK FOR LEAKS; REMOVE PACK CAREFULLY FROM MICROWAVE OVEN AND KNEAD TO DISTRIBUTE HEAT EVENLY. CHECK FOR DESIRED TEMPERATURE. (SEE APPLYING HOT PACK TO SKIN); TO REHEAT, PLACE HOT PACK BACK IN MICROWAVE FOR 15 SECONDS INTERVALS UNIT DESIRED TEMPERATURE IS REACHED. KNEAD PACK AGAIN TO DISTRIBUTE HEAT. APPLYING HOT PACK TO SKIN: CHECK FOR LEAKS; INSERT PACK IN COVER OR WRAP IN CLOTH; CHECK FOR DESIRED TEMPERATURE BY CAREFULLY PLACING COVERED PACK AGAINST FOREARM. IF TOO HOT, LET COOL. WHEN COMFORTABLE, APPLY PACK TO DESIRE AREA. REMOVE PACK IF IT BECOMES UNCOMFORTABLE. (B)(4).

Description of Event or Problem

CUSTOMER REPORTS: SHE PURCHASED A NEW COMPRESS. SHE HAD A PIMPLE BEHIND HER EAR DRUM AND HER DOCTOR SUGGESTED SHE APPLY HEAT TO HER EAR. SHE STATES SHE FOLLOWED THE DIRECTIONS ON THE PACKAGE - 30 SECONDS IN THE MICROWAVE. SHE DOES NOT KNOW THE WATTAGE OF HER MICROWAVE. WHEN SHE WENT TO PUT THE COMPRESS IN THE SLEEVE, IT EXPLODED MAKING THE HOT GEL CAUSE A BURN ON HER NECK, CHEST, RIGHT ARM AND LEFT HAND. THE AREA BLISTERED AND TOOK 10 DAYS TO HEAL. TODAY THE SKIN IS STILL PINK, BUT MUCH BETTER.