FDA Adverse Event
Malfunction
Summary report: N
GUM® TRAV-LER® INTERDENTAL BRUSH (0.6MM); BULK; 50/BAG
MDR report key: 21193173
·
Received January 20, 2025
Report
- Report Number
- 1413787-2025-00168
- Event Type
- Malfunction
- Date Received
- January 20, 2025
- Date of Event
- December 19, 2024
- Report Date
- January 20, 2025
- Manufacturer
- SUNSTAR AMERICAS, INC
- Product Code
- EFW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
CUSTOMER BOUGHT GUM® TRAV-LER® INTERDENTAL BRUSH, THEY ALL BUCKLED, BUT THE LIGHT BLUE ONE EVEN STARTED TO LOSE BRISTLES.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 488500 | GUM® TRAV-LER® INTERDENTAL BRUSH (0.6MM); BULK; 50/BAG | INTERDENTAL BRUSH | EFW | SUNSTAR AMERICAS, INC | 1312BC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |