FDA Adverse Event
Malfunction
Summary report: N
PRECISION TOOTHBRUSH
MDR report key: 14679
·
Received July 14, 1994
Report
- Report Number
- MW1002818
- Event Type
- Malfunction
- Date Received
- July 14, 1994
- Date of Event
- June 1, 1994
- Report Date
- June 29, 1994
- Manufacturer
- COLGATE-HOYT LABORATORIES
- Product Code
- EFW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NV, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
THE PT WAS USING A TOOTHBRUSH AND FELT A PIECE OF METAL IN HER MOUTH. UPON INSPECTING THE TOOTHBRUSH IT WAS NOTED THAT THE BRUSH CONTAINS METAL PIECES SET IN THE BRISTLE HOLDINGS. THE PT DID NOT RECEIVE ANY INJURIES IN HER MOUTH OTHER THAN THE DISCOMFORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION TOOTHBRUSH | TOOTHBRUSH | EFW | COLGATE-HOYT LABORATORIES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other |