FDA Adverse Event
Malfunction
Summary report: N
IDB PROXABRUSH
MDR report key: 17769683
·
Received September 18, 2023
Report
- Report Number
- 0001413787-2023-00067
- Event Type
- Malfunction
- Date Received
- September 18, 2023
- Date of Event
- September 4, 2023
- Manufacturer
- SUNSTAR AMERICAS INC.
- Product Code
- EFW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
A CONSUMER WAS USING THE GUM PROXABRUSH AND NOTICED THE WIRE WAS BREAKING AT THE NECK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1088555 | IDB PROXABRUSH | TOOTHBRUSH, MANUAL | EFW | SUNSTAR AMERICAS INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male |