MalfunctionMPO
NOVAPLUS INFANT HEEL WARMER SQUEEZE
Received Mar 29, 2023 · Event occurred Feb 27, 2023
Report 1423537-2023-00894 · MDR key 16640520
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Mo016 Mo-moberlyModel number
V11460-010Catalog number
V11460-010
Lot number
V2S056 E
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
HOLD NBII 3/30 CUSTOMER STATED RN SQUEEZED HEEL WARMER TO ACTIVATE, HEEL WARMER EXPLODED AND INSIDE MATERIAL GOT ON NURSE, UNIFORM, FLOOR. NO INJURY OR ADVERSE EVENT WAS REPORTED.