InjuryDYJ
CLEAR ORTHO RETAINER
Received Oct 10, 2023
Report 3011649314-2023-00590 · MDR key 17906756
Device
Generic name
Thermoform Retainer
Manufacturer
Prismatik Dentalcraft, Inc.Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Unknown
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED. IF/WHEN THERE IS MORE INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
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 SWOLLEN AND RED GUMS. THERE ARE NO REPORTED ALLERGIES.