inforMED
InjuryMPO

CARDINAL INFANT HEEL WARMER

Received Jul 19, 2022 · Event occurred Jun 8, 2022

Report MW5110973 · MDR key 15067026

Device

Generic name

Infant Heel Warmer (chemical Heat Pack)

Model number

11460-010T

Catalog number

11460-010T

Lot number

V2C235

Product problems

  • Gel Leak

Patient

Unknown

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

Narrative

Description of Event or Problem

BEFORE CHECKING THE BABY'S BLOOD SUGAR THE HEEL WARMER POPPED OPEN AND CONTENTS SPLATTERED ON SINK AND ACCUCHECK MACHINE. FDA SAFETY REPORT ID# (B)(4).