INFANT HEEL WARMER,SQUEEZE, 4X4IN

Additional Manufacturer Narrative

DEVICE HISTORY REVIEW WAS COMPLETED ON THE REPORTED LOT NUMBER V2B263. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. THE ACTUAL COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION ALREADY ACTIVATED. THE ROOT CAUSE WAS DETERMINED TO BE A CUT POUCH. IT IS VERY UNLIKELY THIS POUCH WAS CUT BEFORE LEAVING THE MANUFACTURING SITE; THE PRODUCT WAS NOT REWORKED, AND EMPLOYEES ARE NOT TO OPEN SHIPPERS USING SHARP INSTRUMENTS. FURTHER, SHIPPER ARTWORK INSTRUCTS ¿DO NOT USE KNIFE TO OPEN.¿ THEREFORE, THE ROOT CAUSE IS LIKELY DUE TO THE CUSTOMER FAILING TO FOLLOW PACKAGING DIRECTIONS. WE WILL CONTINUE TO MONITOR TRENDS FOR THIS PRODUCT.

Description of Event or Problem

WHEN THE NURSE WENT TO ACTIVATE THE PACKAGE IT EXPLODED INTO HER HAND. SHE WAS NOT HURT, SHE QUICKLY WASHED IT OFF SHE STATED IT WAS A SLIGHT BURNING SENSATION BUT NOTHING ELSE.