FDA Adverse Event
Injury
Summary report: N
ADVANCED CARE FLOSSER PICKS
MDR report key: 14148420
·
Received April 19, 2022
Report
- Report Number
- 0001413787-2022-00075
- Event Type
- Injury
- Date Received
- April 19, 2022
- Date of Event
- March 29, 2022
- Report Date
- March 29, 2022
- Manufacturer
- SUNSTAR AMERICAS INC.
- Product Code
- JET
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
CONSUMER WAS USING A PACK OF THE ADVANCED CARE FLOSSER PICKS AND WITH THE FIRST ONE HE USED, HE CHIPPED HIS TOOTH AND HIS TOOTH IS NOW IN PIECES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1266870 | ADVANCED CARE FLOSSER PICKS | PICK, MASSAGING | JET | SUNSTAR AMERICAS INC. | 888A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other |