NOVAPLUS INFANT HEEL WARMER SQUEEZE
Received May 12, 2023 · Event occurred Apr 5, 2023
Report 1423537-2023-00936 · MDR key 16924741
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Mo016 Mo-moberlyModel number
V11460-010Catalog number
V11460-010
Lot number
V2S056
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT V2S056. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. A SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED FOR THIS PRODUCT. WE WILL CONTINUE TO MONITOR TRENDS FOR THIS PRODUCT.
Description of Event or Problem
MEDWATCH MW5116504 STATED THE CUSTOMER REPORTED THAT THEY HAVE HAD SEVERAL INSTANCES OF THE NOVAPLUS INFANT HEEL WARMER EXPLODING WHEN SQUEEZING FOR ACTIVATION, WHICH CAN RESULT IN INJURY TO STAFF AND/OR PATIENTS. IT IS UNCLEAR AT THIS TIME IF THIS IS ISOLATED TO A SPECIFIC LOT NUMBER. CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION UPON REQUEST.