INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received Jun 7, 2022 · Event occurred Jan 1, 1980
Report 1423537-2022-00783 · MDR key 14627909
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Cardinal Health 200, LlcModel number
11460-010TCatalog number
11460-010T
Lot number
V2C242
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 COMPLETED ON THE REPORTED LOT V2C242. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. SAMPLE WAS NOT RETURNED FOR EVALUATION DUE TO WHICH A ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR TRENDS FOR THIS PRODUCT.
Description of Event or Problem
CUSTOMER REPORTED THAT INFANT HEEL WARMER POPPED OPEN AT THE SEAL UPON ACTIVATION. NO ADVERSE EVENT WAS REPORTED. EVENT DATE WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.