MalfunctionMPO
INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received Jul 20, 2022 · Event occurred Jan 1, 1980
Report 1423537-2022-00809 · MDR key 15065597
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
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DEVICE HISTORY REVIEW WAS NOT COMPLETED BECAUSE A LOT NUMBER WAS NOT PROVIDED. 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 RN¿S GLOVED HANDS. THE CONTENTS WERE WASHED OFF AND NO INJURY OR ADVERSE EFFECT REPORTED. NO DEMOGRAPHICS PROVIDED.