INFANT HEEL WARMER SQUEEZE 4X4IN
Received Jul 13, 2023 · Event occurred Jun 16, 2023
Report 1423537-2023-00959 · MDR key 17321832
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Mo016 Mo-moberlyModel number
11460-010TCatalog number
11460-010T
Lot number
V2S065E
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
THE COMPLAINT WAS FORWARDED TO THE MANUFACTURING FACILITY WHERE IT IS CURRENTLY STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.
Description of Event or Problem
CUSTOMER REPORTED HEEL WARMER EXPLODED IN ANOTHER NURSE¿S FACE. THERE WAS NO INJURY. NO FURTHER INFORMATION WAS PROVIDED WHEN REQUESTED.
Additional Manufacturer Narrative
AS NO SAMPLES WERE RETURNED FOR EVALUATION. A ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT#: V2S065, WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND, DURING REVIEW OF THE RECORDS. CARDINAL HEALTH WILL CONTINUE TO MONITOR AND TREND ALL SIMILAR REPORTED PRODUCT RELATED ISSUES.