INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received Sep 24, 2022 · Event occurred Jul 15, 2022
Report 1423537-2022-00845 · MDR key 15480421
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Cardinal Health 200, LlcModel number
11460-010TCatalog number
11460-010T
Lot number
V2C235D
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CUSTOMER REPORTED WHEN HEEL WARMER WAS SQUEEZED TO ACTIVATE, ITS CONTENTS OOZED OUT OF THE BOTTOM SEAM AND LANDED IN ASSOCIATE¿S EYE. NO INJURY REPORTED, SHE ONLY REQUIRED EYE FLUSHING. NO OTHER DEMOGRAPHICS PROVIDED.
Additional Manufacturer Narrative
DEVICE HISTORY REVIEW WAS COMPLETED ON THE REPORTED LOT NUMBER V2C235. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR TRENDS FOR THIS PRODUCT.