FDA Adverse Event
Malfunction
Summary report: N
GUM SENSITIVE CARE TOOTHBRUSH
MDR report key: 14349804
·
Received May 10, 2022
Report
- Report Number
- 0001413787-2022-00138
- Event Type
- Malfunction
- Date Received
- May 10, 2022
- Date of Event
- September 17, 2019
- Report Date
- September 17, 2019
- Manufacturer
- SUNSTAR AMERICAS INC.
- Product Code
- EFW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS MDR REPORT IS GENERATED RETROSPECTIVELY BASED ON COMPLAINTS AUDIT.
Description of Event or Problem · 0
CONSUMER WAS USING THE GUM SENSITIVE CARE TOOTHBRUSH WITH THE SOFT BRISTLES. THE BRISTLES THEN GOT CAUGHT BETWEEN HIS TEETH MORE THAN ONCE AND GOT LODGED BETWEEN HIS TEETH AND RIPPED OUT OF THE TOOTHBRUSH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 694991 | GUM SENSITIVE CARE TOOTHBRUSH | TOOTHBRUSH, MANUAL | EFW | SUNSTAR AMERICAS INC. | 516VP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male |