InjuryEGJ
IONTO4
Received Aug 7, 2025 · Event occurred Jul 29, 2025
Report 2118418-2025-00001 · MDR key 22742008
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
60 YR · Female
- Blister
- Blister
Narrative
Description of Event or Problem
WHILE USING THE IONTO4, A PATIENT HAD A SEVERE REACTION. THE MEDICAL STAFF TESTING THE PATIENT COULD NOT DETERMINE WHETHER THE REACTION WAS A BURN OR AN ALLERGY.
Remedial action
- Inspection