INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received Sep 24, 2022 · Event occurred Jul 15, 2022
Report 1423537-2022-00848 · MDR key 15481348
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Cardinal Health 200, LlcModel number
11460-010TCatalog number
11460-010T
Lot number
UNKNOWN
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 THAT WHEN THE HEEL WARMER WAS SQUEEZED TO ACTIVATE, ITS CONTENTS OOZED OUT ON ASSOCIATE. NO INJURY REPORTED OR OTHER DEMOGRAPHICS PROVIDED.
Additional Manufacturer Narrative
DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE COMPLETED AS NO LOT NUMBER WAS AVAILABLE FOR EVALUATION. THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, AN EVALUATION OF THE COMPLAINT SAMPLE FOR DEFICIENCY OF CONSTRUCTION COULD NOT BE PERFORMED. THE ROOT CAUSE WAS NOT DETERMINED. WE WILL CONTINUE TO MONITOR TRENDS FOR THIS PRODUCT.