FDA Adverse Event
Injury
Summary report: N
SUPER SLIP FLOSSER
MDR report key: 4232918
·
Received November 6, 2014
Report
- Report Number
- 1825660-2014-00942
- Event Type
- Injury
- Date Received
- November 6, 2014
- Date of Event
- October 8, 2014
- Report Date
- November 5, 2014
- Manufacturer
- RANIR, LLC
- Product Code
- JES
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER STATED THAT SHE WAS FLOSSING AND WHEN SHE PULLED THE FLOSSER OUT, HER FILLING CAME UP. SHE HAD TO PAY (B)(6) TO REPAIR IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 713261 | SUPER SLIP FLOSSER | MOUTH GUARD | JES | RANIR, LLC | SUPER SLIP FLOSSER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |