INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received Jul 1, 2022 · Event occurred May 23, 2022
Report 1423537-2022-00800 · MDR key 14893683
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Mo016 Mo-moberlyModel number
11460-010TCatalog number
11460-010T
Lot number
V2C235D
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
Description of Event or Problem
CUSTOMER REPORTED THAT THE INFANT HEEL WARMER EXPLODED DURING ACTIVATION. NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT V2C235. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. 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.