FDA Adverse Event
Summary report: N
FRIDABABY TOOTHBRUSH
MDR report key: 6692630
·
Received July 6, 2017
Report
- Report Number
- MW5070825
- Date Received
- July 6, 2017
- Date of Event
- June 23, 2017
- Report Date
- June 26, 2017
- Manufacturer
- FRIDABABY LLC
- Product Code
- EFW
- Report Source
- Voluntary report
- Reporter Location
- AZ, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
I BOUGHT A FRIDABABY TOOTHBRUSH FOR KIDS (B)(6) YEARS AND OLDER. MY DAUGHTER BIT A PIECE OF THE YELLOW PLASTIC FREE (IT'S A TEAR). IT'S JUST A SOFT YELLOW PLASTIC THAT COVERS THE HARD, WHITE BRUSH. IF SHE BITES THE WHOLE PIECE OFF I COULD SEE THIS EASILY BEING A CHOKING HAZARD. I'M AM GOING TO RETURN IT TO WHERE I BOUGHT IT. DOCUMENT NUMBER: (B)(4). REPORT NUMBER: 20170626-84665-2147399405.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470279 | FRIDABABY TOOTHBRUSH | FRIDABABY TOOTHBRUSH | EFW | FRIDABABY LLC | SMILEBABY FRIDABABY TODDLER TOOTHBRUSH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 MO |