MalfunctionMPO

INFANT HEEL WARMERS 3.75 IN X 5.5 IN.

Received Jul 11, 2025 · Event occurred Apr 16, 2025

Report 22478047 · MDR key 22478047

Device

Generic name

Infant Heel Warmer (chemical Heat Pack)

Manufacturer

Medline Industries, Inc.

Catalog number

MDS138007

Product problems

Crack

Patient

NA · Unknown

Hypothermia
Hypothermia

Narrative

Description of Event or Problem

2 INFANT HEEL WARMERS CRACKED AND FELT COLD. SAVED FOR APSM [ASSISTANT PATIENT SERVICES MANAGER]. MANUFACTURER RESPONSE FOR INFANT HEEL WARMERS 3.75 IN X 5.5 IN., INFANT HEEL WARMERS 3.75 IN X 5.5 IN. (PER SITE REPORTER) [REDACTED] MADE AWARE.