INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received Aug 23, 2021 · Event occurred Jul 14, 2021
Report 1423537-2021-00665 · MDR key 12356842
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Mo016 Mo-moberlyModel number
11460-010TCatalog number
11460-010T
Lot number
V1E144
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
63 YR
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR THE REPORTED LOT NUMBER AND REVEALED IT WAS MANUFACTURED AND RELEASED ON 5/20/2021 TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. THE SAMPLES RECEIVED FOR INVESTIGATION WERE ALREADY ACTIVATED. THE EXACT ROOT CAUSE CANNOT BE DETERMINED BASED ON THE SAMPLES RECEIVED. A WARNING TO THE LABEL FOR THE CUSTOMER TO ACTIVATE AWAY FROM ALL PEOPLE WILL BE ADDED TO THE DEVICE. ADDITIONALLY, WE WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS TYPE OF INCIDENT.
Description of Event or Problem
CUSTOMER REPORT WE ARE CONTINUING HAVING ISSUES WITH THE HEEL WARMERS. THE HEEL WARMERS ARE ALREADY ACTIVATED PRIOR TO USE. I HAD 6 MORE BROUGHT INTO MY OFFICE AND ONE REPORTEDLY BURST AT THE SEAM WHEN A NURSE ACTIVATED IT.