inforMED
MalfunctionMPO

INFANT HELL WARMER

Received Jul 14, 2021 · Event occurred Jun 6, 2021

Report 12165682 · MDR key 12165682

Device

Generic name

Infant Hell Warmer (chemical Heat Pack)

Model number

MDS138007

Lot number

VN20337A1

Product problems

  • Explosion

Patient

Not reported

  • Chemical Exposure
  • Chemical Exposure

Narrative

Description of Event or Problem

AN INFANT HEEL WARMER FROM MEDLINE WAS ACTIVATED BY A NURSE AND SUBSEQUENTLY EXPLODED AND THE CONTENTS SPLATTERED ON THE NURSES CHEST AND FACE MASK. THE NURSE IMMEDIATELY REMOVED THE LIQUID AND NO LASTING HARM WAS NOTED. MANUFACTURER RESPONSE FOR INFANT HEEL WARMER, (BRAND NOT PROVIDED) (PER SITE REPORTER): REPRESENTATIVE WAS RESPONSIVE AND RETRIEVED THE PRODUCT. WE HAVE REQUESTED AN UPDATE ON THE OUTCOME OF THE INVESTIGATION.