INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received Aug 2, 2022 · Event occurred Jan 1, 1980
Report 1423537-2022-00816 · MDR key 15153116
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
- Material Separation
Patient
Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- 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
WHILE ACTIVATING THE HEEL WARMER, THE RN HEARD A POP AND THE SEAM SEPARATED. CONTENTS OF THE HEEL WARMER CAME OUT OF IT WITH FORCE LANDING ON THE NEWBORN¿S SKIN ON LEG. NO INJURY OR FOLLOW UP CARE WAS REPORTED. THE EVENT DATE IS UNKNOWN. NO CLINICAL DATA OR FURTHER INFORMATION WAS PROVIDED BY CUSTOMER.
Additional Manufacturer Narrative
SUPPLEMENTAL REPORT IS BEING FILED FOLLOWING THE SUBMISSION OF THE INITIAL MDR REPORT SUBMITTED ON 8/2/2022 SINCE THE RESULTS OF INVESTIGATION ARE AVAILABLE . DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE COMPLETED AS NO LOT NUMBER WAS AVAILABLE FOR EVALUATION. THE SAMPLE WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, AN EVALUATION OF THE COMPLAINT DEVICE FOR DEFICIENCY OF CONSTRUCTION COULD NOT BE PERFORMED AND THE ROOT CAUSE REMAINS UNKNOWN. WE WILL CONTINUE TO MONITOR TRENDS FOR THIS PRODUCT.