INFANT HEEL WARMER,SQUEEZE, 4X4IN

Additional Manufacturer Narrative

DEVICE HISTORY REVIEW WAS COMPLETED ON THE REPORTED LOT NUMBER V2B110. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORD. NO SAMPLE WAS RETURNED FOR INVESTIGATION. THEREFORE; AN EVALUATION OF THE COMPLAINT DEVICE FOR DEFICIENCY OF CONSTRUCTION COULD NOT BE PERFORMED. WE ARE UNABLE TO DETERMINE A SPECIFIC ASSIGNABLE ROOT CAUSE FOR THE REPORTED INCIDENT. WE WILL CONTINUE TO MONITOR THIS FAILURE MODE FOR THIS PRODUCT.

Description of Event or Problem

CUSTOMER REPORTED UPON ACTIVATION, THE INFANT HEEL WARMER BURST AT THE SEAMS EXPOSING HOT GEL CONTENTS ONTO THE NURSE¿S FACE AND HANDS. CONTENTS WERE WASHED OFF WITH WARM WATER. THERE WAS NO SERIOUS INJURY TO THE NURSE.