inforMED
MalfunctionMPO

CARDINAL HEALTH

Received Aug 30, 2022 · Event occurred Jul 15, 2022

Report 15319497 · MDR key 15319497

Device

Generic name

Infant Heel Warmer (chemical Heat Pack)

Model number

11460-010T

Catalog number

11460-010T

Lot number

V2C235D

Product problems

  • Gel Leak
  • Defective Device

Patient

Unknown

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

Narrative

Description of Event or Problem

WHEN HEEL WARMER SQUEEZED TO ACTIVATE, ITS CONTENTS OOZED OUT OF THE BOTTOM SEAM. REPORTED THAT THIS IS THE 3RD WARMER WITH THE SAME ISSUE (UNSURE IF OTHERS WERE OF SAME LOT).