INFANT HEEL WARMER SQUEEZE 4X4IN
Received May 5, 2023 · Event occurred Apr 12, 2023
Report 1423537-2023-00932 · MDR key 16882267
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Mo016 Mo-moberlyModel number
11460-010TCatalog number
11460-010T
Lot number
V2P123-D
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
Description of Event or Problem
CUSTOMER REPORTED WHEN THE INFANT HEEL WARMER WAS SQUEEZED TO ACTIVATE, THE CONTENTS OF THE PACKET CAME OUT OF THE TOP AND LANDED ON ONE OF THE PATIENTS. THIS HAS HAPPENED TWICE NOW.
Additional Manufacturer Narrative
DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT V2P123. 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.