WARMER,HEEL,INFANT,GEL PK,100CS

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, A HEEL WARMER APPEARED TO HAVE LEAKED ONTO INFANT'S RIGHT HEEL. THE CUSTOMER STATED THAT UPON FURTHER ASSESSMENT, THE HEEL "APPEARED TO BE RED, PAINFUL TO TOUCH, SLOUGHING SKIN AND WEEPY.". THE CUSTOMER SAID THAT THE TOTAL APPLICATION TIME OF THE WARMER WAS 3 TO 5 MINUTES. THE CUSTOMER REPORTED THAT A WOUND RN AND THE BURN TEAM WERE CONSULTED FOR TREATMENT AND FOLLOW-UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, A HEEL WARMER APPEARED TO HAVE LEAKED ONTO INFANT'S RIGHT HEEL. THE CUSTOMER STATED THAT UPON FURTHER ASSESSMENT, THE HEEL "APPEARED TO BE RED, PAINFUL TO TOUCH, SLOUGHING SKIN AND WEEPY.".