DIV 34 REHAB & FALL PREVENTION

Description of Event or Problem

ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 THE CUSTOMER "UNDERWENT A ROUTINE HEEL STICK TO OBTAIN LABS" IN THE NICU AND A "MEDLINE MOM & BABY INFANT HEEL WARMER WAS USED" ON THE RIGHT LEG. THE CUSTOMER REPORTED "THE NURSE NOTED IN THE MEDICAL RECORDS THAT THE HEEL WARMER 'POPPED OPEN' AND SPREAD ONTO THE SITE" AND "OBSERVED REDNESS" TO THE AREA RESULTING IN RIGHT LEG CHEMICAL BURN AND SURGERY.

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 THE CUSTOMER "UNDERWENT A ROUTINE HEEL STICK TO OBTAIN LABS" IN THE NICU AND A "MEDLINE MOM & BABY INFANT HEEL WARMER WAS USED" ON THE RIGHT LEG. THE CUSTOMER REPORTED "THE NURSE NOTED IN THE MEDICAL RECORDS THAT THE HEEL WARMER 'POPPED OPEN' AND SPREAD ONTO THE SITE" AND "OBSERVED REDNESS" TO THE AREA. ACCORDING TO THE CUSTOMER, THE NURSE "CLEANED THE SITE WITH A STERILE SALINE WIPE AND APPLIED BACITRACIN OINTMENT AND THE SITE WAS COVERED WITH A SMALL GAUZE WRAP." THE CUSTOMER REPORTED THAT "LATER THAT DAY" THE BANDAGE WAS REMOVED FOR AN ASSESSMENT AND THE PROVIDER "REPORTED BLISTERS AND BURNED SKIN." THE CUSTOMER SAID THAT A NEONATAL NURSE PRACTITIONER AND THE ATTENDING PHYSICIAN WERE CONSULTED FOR "URGENT EVALUATION." ACCORDING TO THE CUSTOMER, THE EVALUATION REVEALED RIGHT LEG "SEROUS BLISTERING AND LOSS OF SKIN CALF DEEP WITH BLUE HUE AT CALF MEASURING 2X1CM, HEEL WITH OPEN WOUND WITH MILD SKIN EDEMA" AND "LARGE UNROOFED BLISTER 3CMX2.5CM TO LATERAL CALF, SKIN RED AND WEEPING. LATERAL IS AN AREA OF PURPURA FORMATION. SKIN FROM KNEE TO FOOT IS LESS EDEMATOUS AND RED." THE CUSTOMER SAID THAT ON (B)(6) 2024, THE AREA WAS "CLEANED," FLUID WAS CULTURED, AND A "SKIN SUB APPLICATION" SURGICAL PROCEDURE WAS PERFORMED THAT INCLUDED THE "APPLICATION OF SUPRATHEL SKIN SUBSTITUTE TO RIGHT LOWER EXTREMITY WOUND." THE CUSTOMER REPORTED DISCHARGE FROM THE NICU ON (B)(6) 2024. THE CUSTOMER REPORTED HOME CARE AND MULTIPLE FOLLOW UP VISITS FOR THE RLE BURN THROUGH (B)(6) 2024 WITH EXPECTATIONS OF "ADDITIONAL TREATMENT AND PROCEDURES IN THE FUTURE FOR SCAR MANAGEMENT." 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.