NOVAPLUS INFANT HEEL WARMER 4X4IN

Description of Event or Problem

CUSTOMER REPORTED A HEEL WARMER BURST IN A NURSE¿S FACE AND WENT ALL OVER A BABY. THE NURSE WENT TO THE EMERGENCY ROOM WHERE AN EYE RINSE WAS DONE, AND HER FACE WAS CLEANED WITH A WASHCLOTH. THE BABY WAS WASHED OFF AND HIS T-SHIRT AND LINEN WERE CHANGED. AT PRESENT BOTH ARE DOING FINE. CUSTOMER STATES THEY DID NOT RECORD THE LOT # OF THE PRODUCT INVOLVED AND IS NOT SURE WHICH LOT NUMBER THEY PULLED THE ITEM FROM. THEY PROVIDED ALL LOT NUMBERS THAT WERE ON THEIR CART AT THE TIME OF THE INCIDENT.

Additional Manufacturer Narrative

DEVICE HISTORY REVIEW WAS COMPLETED ON THE FOLLOWING POTENTIAL LOT NUMBERS: #V1N223, #V1L088, AND #V1N203. THE LOTS WERE FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. THERE WERE NO SAMPLES AVAILABLE, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS INFORMED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. ISSUE WILL BE MONITORED THROUGH ROUTINE COMPLAINT TREND ANALYSIS. SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT. ADDITIONALLY, A WARNING LABEL WILL BE ADDED WHICH INDICATES THE USER IS TO "ACTIVATE AWAY FROM THE USER'S FACE AND AWAY FROM THE INFANT AND OTHERS".