NOVAPLUS INFANT HEEL WARMER 4X4IN
Received Jun 3, 2022 · Event occurred Jan 1, 1980
Report 1423537-2022-00776 · MDR key 14598381
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Cardinal Health 200, LlcModel number
V11460-010Catalog number
V11460-010
Lot number
V2A051
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 REVIEW (DHR) WAS COMPLETED ON THE REPORTED LOT V2A051. 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 INVESTIGATION, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR TRENDS FOR THIS PRODUCT.
Description of Event or Problem
CUSTOMER REPORTED THAT WHEN ACTIVATING THE INFANT HEEL WARMER AS INSTRUCTED, IT BURST AND CONTENTS WENT ACROSS THE ROOM HITTING STAFF MEMBER¿S JACKET. THERE WAS NO SKIN EXPOSURE OR ADVERSE EVENT. EVENT DATE IS UNKNOWN.