FDA Adverse Event
Malfunction
Summary report: N
INTERDENTAL-SOFT-PICKS
MDR report key: 13997752
·
Received April 4, 2022
Report
- Report Number
- 0001413787-2022-00069
- Event Type
- Malfunction
- Date Received
- April 4, 2022
- Date of Event
- March 7, 2022
- Report Date
- March 7, 2022
- Manufacturer
- SUNSTAR AMERICAS INC.
- Product Code
- JET
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
CONSUMER STATED SHE PURCHASED SOFT PICKS AND THE BRISTLES STARTED TO FALL OFF DURING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1240577 | INTERDENTAL-SOFT-PICKS | PICK, MASSAGING | JET | SUNSTAR AMERICAS INC. | 650, 632 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |