MalfunctionMPO

INFANT HEEL WARMER SQUEEZE 4X4IN

Received Jun 11, 2024 · Event occurred May 15, 2024

Report 1423537-2024-00023 · MDR key 19511551

Device

Generic name

Infant Heel Warmer (chemical Heat Pack)

Manufacturer

Mo016 Mo-moberly

Model number

11460-010T

Catalog number

11460-010T

Lot number

V2E092

Product problems

Burst Container or Vessel
Burst Container or Vessel

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

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 V2E092, 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

EXPLODED IN THEIR HANDS WHILE THEY WERE WARMING INFANTS HEEL.