INFANT HEEL WARMER SQUEEZE 4X4IN

Additional Manufacturer Narrative

ONE UN-USED SAMPLE WAS RETURNED FOR EVALUATION AND ACTIVATED IN THE LAB WITHOUT ISSUE. AS NO ISSUES WERE FOUND DURING INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT NUMBER- V2E106, AND THE LOT WAS MANUFACTURED AND RELEASED IN COMPLIANCE WITH ALL REQUIREMENTS. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS REPORTED ISSUE.

Description of Event or Problem

INFANT HEEL WARMER BURST WHILE WARMING. THERE HAS BEEN NO INJURY REPORTED. NO FURTHER INFORMATION, CLINICAL DATA, OR PATIENT DEMOGRAPHICS WERE PROVIDED WHEN REQUESTED.