NOVAPLUS INFANT HEEL WARMER SQUEEZE

Additional Manufacturer Narrative

AT THE TIME OF THIS INVESTIGATION, THE DEVICE HISTORY RECORD COULD NOT BE VERIFIED AS A LOT NUMBER WAS NOT PROVIDED. A SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR COMPLAINT TRENDS AND UTILIZE THE INFORMATION AS PART OF CONTINUOUS IMPROVEMENT.

Description of Event or Problem

MEDWATCH REPORT STATES THE NOVAPLUS INFANT HEEL WARMER PACKETS (TEAL/WHITE PACKAGING) IS "EXPLODING" WHEN ACTIVATED. WHEN SQUEEZED TO ACTIVATE THE CONTENTS, THE SEAL ON THE PACKAGING OPENS UP AND THE CONTENTS SPRAY ACROSS THE AREA. ONE STAFF HAS MADE CONTACT WITH HER SKIN AND CAUSED SOME IRRITATION. DEFECTIVE ITEM DID NOT REACH THE BABY. NO CUSTOMER CONTACT INFORMATION PROVIDED.