FDA Adverse Event
Malfunction
Summary report: N
IDB PROXABRUSH
MDR report key: 16810833
·
Received April 25, 2023
Report
- Report Number
- 0001413787-2023-00032
- Event Type
- Malfunction
- Date Received
- April 25, 2023
- Date of Event
- April 12, 2023
- Report Date
- April 25, 2023
- Manufacturer
- SUNSTAR AMERICAS INC.
- Product Code
- EFW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
A CONSUMER WAS USING AN IDB PROXABRUSH AND STATED THAT THE TIP BROKE OFF BETWEEN HIS IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1092676 | IDB PROXABRUSH | TOOTHBRUSH, MANUAL | EFW | SUNSTAR AMERICAS INC. | 871FC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male |