MalfunctionMPO
CARDINAL HEALTH
Received Apr 7, 2026 · Event occurred Jan 4, 2026
Report 24799413 · MDR key 24799413
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Cardinal Health 200, LlcModel number
11460-010TCatalog number
11460-010T
Lot number
VN24062A26
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON [REDACTED], INFANT HEEL WARMER BECAME COLD AND GRITTY IN TEXTURE WHEN ACTIVATED RATHER THAN WARM AND SMOOTH TEXTURE. HEEL WARMER BEGAN LEAKING CRYSTALLIZED FLUID FROM BOTTOM SEAM. MANUFACTURER RESPONSE FOR INFANT HEEL WARMER (CHEMICAL HEAT PACK), CARDINAL HEALTH (PER SITE REPORTER). NOTIFIED CARDINAL [REDACTED DATE].