INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received May 24, 2022 · Event occurred Jan 1, 1980
Report 1423537-2022-00770 · MDR key 14492322
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Cardinal Health 200, LlcModel number
11460-010TCatalog number
11460-010T
Lot number
V2B110
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
Additional Manufacturer Narrative
DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT NUMBER V2B110. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. NO SAMPLES WERE RETURNED FOR EVALUATION THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS ISSUE.
Description of Event or Problem
CUSTOMER HAS REPORTED THAT THE SEAM OF THE PRODUCT BURST, EXPOSING HOT GEL CONTENTS WHEN ACTIVATING. THE PACK MATERIAL LANDED ON CLINICIAN'S HAND AND FACE. THE PRODUCT WAS WIPED OFF WITH WARM WATER. NO MEDICATION OR INJURY WAS NOTED FOR THE AFFECTED PERSON. THE EVENT DATE IS UNKNOWN.