NOVAPLUS INFANT HEEL WARMER SQUEEZE
Received Apr 26, 2023 · Event occurred Mar 31, 2023
Report 1423537-2023-00914 · MDR key 16812632
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Mo016 Mo-moberlyModel number
V11460-010Catalog number
V11460-010
Lot number
V2S056 E
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CUSTOMER REPORTED NURSE WAS SQUEEZING TO ACTIVE THE HEEL WARMER WHEN THE BAG EXPLODED INTO HER FACE, HAIR, CHEST, AND ABDOMEN. NO INJURY REPORTED.
Additional Manufacturer Narrative
THE SAMPLE WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, THE ROOT CAUSE REMAINS UNKNOWN. DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT NUMBER V2S056. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. NO FURTHER ACTION WILL BE TAKEN AT THIS TIME. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS REPORTED ISSUE.