INFANT HEEL WARMER SQUEEZE 4X4IN
Received Jul 14, 2023 · Event occurred Jan 1, 1980
Report 1423537-2023-00960 · MDR key 17328020
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Mo016 Mo-moberlyModel number
11460-010TCatalog number
11460-010T
Lot number
V2S065
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
36 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT HAS BEEN REPORTED THAT A CARDINAL HEALTH HEEL WARMER BURST WHILE BEING ACTIVATED BY A NURSE, LANDING IN HER EYE. PAIN AND REDNESS OF RN¿S EYE WAS NOTED, THE EYE WAS FLUSHED WITH SALINE, AND NO OTHER MEDICATION WAS PROVIDED. THE PACK MATERIAL WAS REMOVED BY COLD WATER IN THE SINK. THE NURSE REPORTED NO ISSUES AFTER THE INCIDENT.
Additional Manufacturer Narrative
NO SAMPLES WERE RETURNED BY THE CUSTOMER AND THEREFORE WE ARE UNABLE TO CONFIRM THE ROOT CAUSE FOR THE ISSUE REPORTED. DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT V2S065.THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. CARDINAL HEALTH WILL CONTINUE TO MONITOR AND TREND ALL REPORTED PRODUCT RELATED ISSUES FOR THIS PRODUCT.