INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received Jul 20, 2022 · Event occurred Jun 19, 2022
Report 1423537-2022-00807 · MDR key 15065114
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Cardinal Health 200, LlcModel number
11460-010TCatalog number
11460-010T
Lot number
V2E092
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 WAS COMPLETED ON THE REPORTED LOT NUMBER, V2E092. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. THE ACTUAL CUSTOMER SAMPLE WAS NOT RETURNED FOR EVALUATION; 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 THE INFANT HEEL WARMER WAS SQUEEZED TO ACTIVATE, IT BURST AND SQUIRTED OUT ALL OVER INFANT¿S LEG. THERE WAS NO INJURY OR ADVERSE EFFECT REPORTED, CONTENTS REMOVED WITH INFANT WIPES.