InjuryDYJ
CLEAR ORTHO RETAINER
Received Oct 6, 2023
Report 3011649314-2023-00622 · MDR key 17888792
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Prefer Not To Disclose
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT HAD A REACTION TO THE CLEAR ORTHO RETAINER THAT WAS ISSUED. IT IS UNCLEAR WHEN THE PATIENT RECEIVED THE DEVICE, WHEN THE PATIENT FIRST USED THE DEVICE, OR WHEN THE REACTION OCCURRED OR RESOLVED. IT IS NOTED THAT THE PATIENT EXPERIENCED INTRAORAL BLISTERS, REDNESS, AND IRRITATIONS. THE DEVICE WAS WORN IN THE MORNING AND THE SYMPTOMS RESOLVED 30 MINUTES AFTER THE DEVICE WAS TAKEN OFF. THERE ARE NO REPORTED ALLERGIES.
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED. IF/WHEN THERE IS MORE INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.