NOVAPLUS INFANT HEEL WARMER 4X4IN

Additional Manufacturer Narrative

A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR THE REPORTED LOT AND THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. A SAMPLE WAS RECEIVED FOR INVESTIGATION THAT WAS ALREADY ACTIVATED AND THERE WAS A NOTED VOID IN THE SEAM OF THE PRODUCT. THE EXACT ROOT CAUSE CANNOT BE DETERMINED BASED ON THE SAMPLE RECEIVED. A WARNING TO THE LABEL FOR THE CUSTOMER TO ACTIVATE AWAY FROM ALL PEOPLE WILL BE ADDED TO THE DEVICE.

Description of Event or Problem

CUSTOMER REPORTED THAT THE ITEM BUSTED OPEN AFTER HEATING CORRECTLY. THE INFANT HEEL WARMER SEAM OPENED, AND INSIDE OF PRODUCT WAS EXPOSED. THE STAFF RECOGNIZED THE ISSUE BEFORE IT CONTACTED THE PATIENT. NO INJURY WAS REPORTED.