NOVAPLUS INFANT HEEL WARMER SQUEEZE
Received Jun 15, 2023 · Event occurred Jan 1, 1980
Report 1423537-2023-00951 · MDR key 17140014
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Mo016 Mo-moberlyModel number
V11460-010Catalog number
V11460-010
Lot number
UNKNOWN
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
NO SAMPLES WERE RETURNED FOR EVALUATION, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED. CARDINAL HEALTH WILL CONTINUE TO MONITOR AND TREND ALL REPORTED PRODUCT RELATED ISSUES.
Description of Event or Problem
CUSTOMER REPORTED THAT THE CLINICIAN POPPED THE HEEL WARMER LIKE NORMAL, NO EXTRA FORCE, NEAR THE BEDSIDE IN TRIAGE. IT EXPLODED TOWARDS THE FOOT OF THE BED AT PATIENT'S SHOULDER WITH GEL GETTING ON HIS JACKET. IT ALSO GOT ON CLINICIAN'S SCRUBS, ON PATIENT BED, AND ON THE FLOOR. THERE WAS NO ADVERSE EFFECT. EVENT DATE IS UNKNOWN.