INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received Jul 1, 2022 · Event occurred Jun 6, 2022
Report 1423537-2022-00799 · MDR key 14893507
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Mo016 Mo-moberlyModel number
11460-010TCatalog number
11460-010T
Lot number
V2C148
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
Male
- 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 V2C148. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. WE RECEIVED 1 SAMPLE ON 6/21/2022. THE SAMPLE WAS ALREADY ACTIVATED. THE ROOT CAUSE WAS DETERMINED TO BE VOID IN THE TOP SEAL RESULTING FROM IMPROPER MACHINE/ EQUIPMENT SETUP. THE PRODUCTION TEAM WAS NOTIFIED OF THE COMPLAINT FOR HEIGHTENED AWARENESS AND THE IMPORTANCE OF ENSURING TEAMS ARE VERIFYING THAT THE MACHINE IS SETUP CORRECTLY AND FUNCTIONING AS INTENDED AFTER ANY MAINTENANCE IS PERFORMED. WE WILL CONTINUE MONITORING TRENDS FOR THIS PRODUCT.
Description of Event or Problem
CUSTOMER REPORTED THAT WHEN THE INFANT HEEL WARMER WAS ACTIVATED, THE PRODUCT OPENED UP AND THE CONTENTS SPLASHED IN THE LAB ASSISTANT'S EYE CAUSING EYE IRRITATION. NO TREATMENT WAS REQUIRED, ONLY RINSING OF EYE IN WATER. NO FURTHER DETAILS WERE PROVIDED.