InjuryDYJ
CLEAR ORTHO RETAINER
Received Oct 11, 2023
Report 3011649314-2023-00640 · MDR key 17916327
Device
Generic name
Thermoform Retainer
Manufacturer
Prismatik Dentalcraft, Inc.Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Female
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS BEEN RETURNED. WHEN THE INVESTIGATION IS COMPLETED, 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. THE PATIENT HAD RED PATCHES ON HER NECK AND OUTSIDE OF MOUTH. THE ALLERGIC REACTION STARTED ABOUT 2 WEEKS TO A MONTH AFTER FIRST WEARING THE DEVICE. THE REACTION WENT AWAY WHEN THE PATIENT STOPPED WEARING THE RETAINER.