INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received Nov 4, 2022 · Event occurred Jan 1, 1980
Report 1423537-2022-00856 · MDR key 15735129
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
A SUPPLEMENTAL REPORT IS BEING FILED SINCE INVESTIGATION RESULTS ARE AVAILABLE FOLLOWING THE SUBMISSION OF THE INITIAL MDR REPORT THAT WAS SUBMITTED ON 11/4/2022. DEVICE HISTORY RECORD REVIEW COULD NOT BE VERIFIED AS LOT NUMBER WAS NOT PROVIDED. NO SAMPLES WERE RETURNED FOR INVESTIGATION DUE TO WHICH A ROOT CAUSE COULD NOT BE DETERMINED. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS PRODUCT.
Additional Manufacturer Narrative
THIS COMPLAINT WAS FORWARDED TO THE MANUFACTURING FACILITY WHERE IT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.
Description of Event or Problem
CUSTOMER HAS REPORTED THAT THE CARDINAL HEALTH INFANT HEEL WARMER BURST WHILE ACTIVATING. THERE HAS BEEN NO INJURY REPORTED AND THE EVENT DATE IS UNKNOWN. NO FURTHER INFORMATION, CLINICAL DATA, OR PATIENT DEMOGRAPHICS WERE PROVIDED WHEN REQUESTED.