inforMED
InjuryMPO

CARDINAL INFANT HEEL WARMER

Received Jul 19, 2022 · Event occurred Jun 22, 2022

Report MW5110974 · MDR key 15067032

Device

Generic name

Infant Heel Warmer (chemical Heat Pack)

Model number

11460-010T

Catalog number

11460-010T

Lot number

V2C235

Product problems

  • Material Rupture
  • Unexpected Therapeutic Results

Patient

Unknown

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

Narrative

Description of Event or Problem

DURING THE ADMISSION OF A BABY TO THE SPECIAL CARE NURSERY A HEEL WARMER WAS OBTAINED. WHEN SQUEEZING THE HEEL WARMER TO ACTIVATE IT TO PLACE ON PATIENT, THE WARMER EXPLODED IN MY HAND WHICH CAUSED THE CONTENT INSIDE TO SPRAY ACROSS ROOM. THE CONTENT CAME INTO CONTACT AND LANDED ON BABY AND ANOTHER NURSE. BABY CLEANED IMMEDIATELY WITH SOAP AND WATER. SKIN WAS ASSESSED NO EVIDENCE NOTED OF ANY REACTION OR REDNESS. NNP WAS NOTIFIED AND CONTINUED TO MONITOR BABY. FDA SAFETY REPORT ID# (B)(4).