NOVAPLUS INFANT HEEL WARMER 4X4IN
Received Apr 4, 2022 · Event occurred Mar 7, 2022
Report 1423537-2022-00742 · MDR key 14000046
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Mo016 Mo-moberlyModel number
V11460-010Catalog number
V11460-010
Lot number
V1N078
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
49 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT THE HEEL WARMER EXPLODED ON A NURSE IN THE NICU WHEN SHE SQUEEZED IT TO ACTIVATE IT. THERE WAS NO INJURY OR FOLLOW UP CARE REQUIRED.
Additional Manufacturer Narrative
DEVICE HISTORY REVIEW WAS COMPLETED ON THE REPORTED LOT V1N078. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. NO SAMPLES WERE RETURNED FOR EVALUATION DUE TO WHICH A ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR THIS FAILURE MODE FOR THIS PRODUCT.