NOVAPLUS INFANT HEEL WARMER 4X4IN

Description of Event or Problem

NURSES DESCRIBED THAT WHEN THEY SQUEEZE TO ACTIVATE THE PRODUCT, THE POUCH WOULD RUPTURE, AND THE CONTENTS WOULD SPILL OUT. CUSTOMER REPORTED THAT DURING ACTIVATION, THE INFANT HEEL WARMER RUPTURED ONTO NURSE¿S 2ND AND 3RD DIGIT ON LEFT HAND CAUSING ERYTHEMA AND NUMBNESS. HANDS WERE WASHED WITH SOAP AND WATER. NO FURTHER FOLLOW UP CARE WAS REQUIRED. NURSE REPORTED CURRENTLY THE AFFECTED AREA HAS OCCASIONAL TINGLING AFTER 2 WEEKS. ACTUAL EVENT DATE IS UNKNOWN BY CUSTOMER.

Additional Manufacturer Narrative

THE DEVICE HISTORY REVIEW WAS COMPLETED ON THE REPORTED LOT NUMBER V2A051. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. THE REPORTED EVENT COULD NOT BE CONFIRMED, AS NO SAMPLES WERE RETURNED BY THE CUSTOMER FOR EVALUATION. WITHOUT THE SAMPLE A ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR COMPLAINT TRENDS.