NOVAPLUS INFANT HEEL WARMER SQUEEZE
Received May 2, 2023 · Event occurred Jan 1, 1980
Report 1423537-2023-00926 · MDR key 16854166
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
65 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT WHEN STAFF TRIED TO ACTIVATE THE HEAL WARMER FOR A PATIENT, THE HEAL WARMER BURST. IT'S REPORTED THAT IT WAS ALREADY UNDER PRESSURE FROM IT ALREADY BEING ACTIVATED WHICH CAUSED THE HEAL WARMER TO BURST. THERE WAS NO INJURY OR ADVERSE EFFECT CAUSED BY THE HOT PACK.
Additional Manufacturer Narrative
AT THE TIME OF THIS INVESTIGATION, THE DEVICE HISTORY RECORD COULD NOT BE VERIFIED AS A LOT NUMBER WAS NOT PROVIDED. A SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR COMPLAINT TRENDS AND UTILIZE THE INFORMATION AS PART OF CONTINUOUS IMPROVEMENT.