WARMER,HEEL,INFANT,MTL DISC,CLOTH STRAP

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, ON 02/15/2025 THERE WERE "SEVERAL HEEL WARMERS THAT HAD BEEN ATTEMPTED ON THE PATIENT AND LEFT IN THE INCUBATOR", "THE INFANT'S ARM WAS LAYING ON THE WARMERS", AND IT CAUSED A "SEVERE BURN" TO THE INFANTS "MID ARM / ELBOW". THE CUSTOMER REPORTED "THE INCUBATOR IS UNDER A HEAT LAMP AND THE WARMERS POTENTIALLY REHEATED". THE CUSTOMER REPORTED "TREATMENT FOR THE BURN WAS ADMINISTERED" BUT THE SPECIFIC CARE ADMINISTERED COULD NOT BE PROVIDED. THE CUSTOMER REPORTED THE INFANT "MAY REQUIRE PLASTIC SURGERY TO REPAIR THE BURN". NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. 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 02/15/2025 THERE WERE "SEVERAL HEEL WARMERS THAT HAD BEEN ATTEMPTED ON THE PATIENT AND LEFT IN THE INCUBATOR", "THE INFANT'S ARM WAS LAYING ON THE WARMERS", AND IT CAUSED A "SEVERE BURN" TO THE INFANTS "MID ARM / ELBOW."