MUELLER

Description of Event or Problem

A NURSE VISITED A GENTLEMAN WHO USED A REUSABLE COLD/HOT PACK A WEEK PREVIOUSLY. SHE NOTICED A REDDENED, SCABBED AREA BELOW HIS RIGHT KNEE. HE RELATED THAT A WEEK AGO, HE USED THE REUSABLE COLD/HOT PACK FOLLOWING THE DIRECTIONS FOR HOT USE USING BOILING WATER TO HEAT THE PACK. HE PLACED THE PACK IN THE POCKET OF A SPORTS WRAP, PLACED THE WRAP ON HIS KNEE AND FELL ASLEEP. WHEN HE WOKE UP, HE NOTICED A LARGE BLISTER WHICH BROKE OPEN SEVERAL DAYS LATER. THE NURSE RECOMMENDED HE BE SEEN AT AN URGENT CARE CENTER. CUSTOMER WAS TOLD HE HAD A STAGE 2 BURN AND INFECTION.

Additional Manufacturer Narrative

CAUTION STATEMENT ON THE REUSABLE COLD/HOT PACK READ AS FOLLOWS: WHEN COLD-HOT PACK IS BROUGHT TO DESIRED TEMPERATURE, NEVER APPLY TO SKIN WITHOUT A COVER OR WRAPPING. IF COLD OR HEAT IS UNCOMFORTABLE, REMOVE FOR A FEW MOMENTS, THEN REAPPLY TO AREA. IF YOU HAVE A CIRCULATORY PROBLEM, CONSULT A PHYSICIAN BEFORE USING COLD-HOT PACK. CUSTOMER SHOULD HAVE MONITORED IF THE HEAT WAS UNCOMFORTABLE; HE MAY HAVE BEEN IMPAIRED FROM MEDICATIONS. IT IS UNKNOWN IF A PHYSICIAN WAS CONSULTED AS IT IS KNOWN THE CUSTOMER HAS CIRCULATORY ISSUES. CUSTOMER FELL ASLEEP AND DID NOT MONITOR, EVEN IN THE FIRST FEW MINUTES OF APPLICATION, TO CHECK IS HEAT APPLIES WAS OK.