FDA Adverse Event
Malfunction
Summary report: N
BYTE RETAINER
MDR report key: 19992949
·
Received August 15, 2024
Report
- Report Number
- 3014845255-2024-00809
- Event Type
- Malfunction
- Date Received
- August 15, 2024
- Report Date
- November 24, 2025
- Manufacturer
- STRAIGHT SMILE, LLC
- Product Code
- KMY
- UDI-DI
- 00850017524170
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803.
Additional Manufacturer Narrative · 0
A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.
Description of Event or Problem · 0
WHILE USING A BYTE RETAINERS, PATIENT REPORTED THAT THE LOWER EDGE OF THEIR RETAINER IS ROUGH CAUSING CUTTING, BLISTERS AND VERY PAINFUL TO THE INSIDE OF THEIR LOWER LIP. ADVISED PATIENT TO FILE THE AREA OF CONCERN ON THE RETAINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1094480 | BYTE RETAINER | POSITIONER, TOOTH, PREFORMED | KMY | STRAIGHT SMILE, LLC | 00850017524170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |