3M NEXCARE REUSABLE HOT PACK, CATALOG NUMBER 2647

Description of Event or Problem

THIS INFO WAS SUBMITTED 5/18/2001: THE ALLEGED INCIDENT OCCURRED FOLLOWING APPLICATION OF A 3M REUSABLE HOT PACK (CATA-LOG #2647). THE PT NOTICED A LUMP IN HER BREAST, AND, FOLLOWING AN ATTEMPT BY HER PHYSICIAN TO ASPIRATE THE FLUID BY NEEDLE, WAS INSTRUCTED (BY HER PHYSICIAN) TO APPLY A HOT PACK TO THE LUMP IN HER BREAST. IT WAS REPORTED THAT THE HOT PACK WAS APPLIED FOR 30 MINUTES. FOLLOWING REMOVAL OF THE PACK, THE CUSTOMER REPORTED THAT SHE DID NOT FEEL OR SEE ANYTHING UNUSUAL. THE NEXT DAY, SHE REPORTED A PINK MARK ON HER BREAST WHERE THE HOT PACK HAD BEEN. SHE THEN LOOKED AT THE BAG AND NOTICED THERE WAS A LEAK. SHE CALLED HER PHYSICIAN WHO RECOMMENDED THAT SHE GO TO THE HOSP. UPON ARRIVAL AT THE HOSP, THE PT WAS INFORMED THAT SHE HAD SUFFERED A THIRD DEGREE BURN AND SHE WOULD BE ADMITTED TO THE HOSP. WHILE IN THE HOSP, THE CUSTOMER WAS INFORMED SHE WOULD NEED TO HAVE A SKIN GRAFT PROCEDURE. LIFE EXPECTANCY AND ANTICIPATED FAILURE RATE: THIS PRODUCT HAS A LABELED SHELF LIFE OF 5 YEARS. REPEATED HEATING FOR APPROPRIATE TIMES, AS INDICATED IN CO'S INSTRUCTIONS, IS NOT CONSIDERED A CAUSE OF GEL LEAKAGE. EXPERIMENTAL DATA HAVE SHOWN THAT THE NEX-CARE REUSABLE HOT PACK CAN BE RE-HEATED IN A MICROWAVE AN AVERAGE OF 60 TIMES AND STILL PERFORM AS EXPECTED. THE DEVICE ALLEGEDLY USED IN THIS EVENT WAS NOT RETURNED TO 3M, THUS ITS LEAKAGE CANNOT BE CONFIRMED OR INVESIGATED. THE ALLEGED BURN HAS NOT BEEN CONFIRMED, AS THE INVOLVED SUBJECT REFUSED TO ALLOW MEDICAL DETAILS TO BE COMMUNICATED BY HER DR DURING THE COMPLAINT INVESTIGATION. REPORTS OF THIS TYPE ARE VERY RARE ON THE NEXCARE REUSABLE HOT PACK; CO'S COMPLAINT HISTORY INDICATES THAT THE INCIDENCE OF SUCH EVENTS (PER AMOUNT OF PRODUCT/SOLD) HAS NOT INCREASED IN THE LAST 8 YEARS. HOWEVER, 3M HEALTH CARE IS CAREFULLY INVESTIGATING THIS AND THE FEW OTHER COMPLAINTS OF BURN AND/OR LEAKAGE REPORTED IN THE PAST FEW YEARS. IN CO'S INVESTIGATION, CO IS INCLUDING NEXCARE REUSABLE COLD/HOT PACK (WHEN USED AS A HOT PACK), AS WELL AS THE SUBJECT OF YOUR LETTER, NEXCARE REUSABLE HOT PACK. THIS INVESTIGATION IS ONGOING AND INCLUDES A FAILURE MODE AND EFFECT ANALYSIS (FMEA). FINAL RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THIS TIME.

Description of Event or Problem

THE ALLEGED INCIDENT OCCURRED FOLLOWING APPLICATION OF A 3M REUSABLE HOT PACK (CATALOG #2647). THE PT NOTICED A LUMP IN THEIR BREAST, AND, FOLLOWING AN ATTEMPT BY THEIR PHYSICIAN TO ASPIRATE THE FLUID BY NEEDLE, WAS INSTRUCTED (BY THEIR PHYSICIAN) TO APPLY A HOT PACK TO THE LUMP IN THEIR BREAST. IT WAS REPORTED THAT THE HOT PACK WAS APPLIED FOR 30 MINUTES. FOLLOWING REMOVAL OF THE PACK, THE PT REPORTED THAT THEY DID NOT FEEL OR SEE ANYTHING UNUSUAL. THE NEXT DAY, PT REPORTED A PINK MARK ON THEIR BREAST WHERE THE HOT PACK HAD BEEN. PT THEN LOOKED AT THE BAG AND NOTICED THERE WAS A LEAK. PT CALLED THEIR PHYSICIAN WHO RECOMMENDED THAT PT GO TO THE HOSPITAL. UPON ARRIVAL AT THE HOSPITAL, THE PT WAS INFORMED THAT THEY HAD SUFFERED A THIRD DEGREE BURN AND SHOULD BE ADMITTED TO THE HOSPITAL. WHILE IN THE HOSPITAL, THE PT WAS INFORMED THEY WOULD NEED TO HAVE A SKIN GRAFT PROCEDURE. ACCORDING TO THE INFO RECEIVED FROM THE PT, THE SKIN GRAFT PROCEDURE OCCURRED IN 2001. IT WAS ALSO REPORTED THAT THE PACK WAS HEATED FOR 30 SECONDS, TWICE, BECAUSE IT ONLY GOT "LUKEWARM" THE FIRST TIME. IT IS UNKNOWN WHAT WATTAGE MICROWAVE WAS USED FOR HEATING THE HOT PACK.