MalfunctionMPO

INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Received Sep 27, 2023 · Event occurred Aug 14, 2023

Report 17824366 · MDR key 17824366

Device

Generic name

Infant Heel Warmer (chemical Heat Pack)

Manufacturer

Denovo Products, Llc

Catalog number

355

Lot number

012023

Patient

Unknown

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

Narrative

Description of Event or Problem

ONE OF THE NEWBORN HEEL WARMERS SPONTANEOUSLY EXPLODED IN THE SUPPLY ROOM. UPON DISCOVERING THE ISSUE, REMAINING HEEL WARMERS WERE REMOVED, SUPPLY TRAY WAS WASHED WITH SOAP AND WATER. NURSE MANAGER WAS NOTIFIED. A PATIENT WAS NOT INVOLVED.