INFANT HEEL WARMER,SQUEEZE, 4X4IN

Additional Manufacturer Narrative

A DEVICE HISTORY REVIEW WAS COMPLETED ON THE REPORTED LOT V1D033. 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 NOT AVAILABLE FOR INVESTIGATION. PHOTOS OF THE AFFECTED PRODUCT WERE PROVIDED; HOWEVER, THE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE PHOTOS. WITHOUT A SPECIFIC ASSIGNABLE CAUSE, NO SPECIFIC CORRECTIVE ACTIONS CAN BE COMPLETED; HOWEVER, A WARNING LABEL IS BEING ADDED TO THE LABEL OF THE DEVICE THAT SPECIFIES THAT ¿WHEN ACTIVATING, HOLD AWAY FROM PATIENT".

Description of Event or Problem

CUSTOMER REPORTED THAT THE HEEL WARMER BROKE WHEN THE PRODUCT WAS SQUEEZED TO ACTIVATE WARMER. CONTENTS STAINED THE FLOOR AND PANTS OF PEDIATRIC PATIENT . NO INJURY OR TREATMENT REPORTED.