INFANT HEEL WARMER,SQUEEZE, 4X4IN

Description of Event or Problem

AS REPORTED THOUGH MED WATCH REPORT MW5110972. A HEALTH PROFESSIONAL THAT ELECTED NOT TO BE IDENTIFIED, REPORTED THAT A HEEL WARMER BURST ONTO NURSE, PATIENT WARMER, CURTAINS, AND ONTO FLOOR. NO INJURY WAS REPORTED. WE ARE UNABLE TO FOLLOW UP WITH THE HEALTH PROFESSIONAL SINCE NO CONTACT INFORMATION WAS PROVIDED ON THE MEDWATCH REPORT.

Additional Manufacturer Narrative

DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED SINCE A LOT NUMBER WAS NOT PROVIDED. NO SAMPLES WERE RETURNED FOR EVALUATION THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS ISSUE.