FDA Adverse Event
Injury
Summary report: N
VOCO PROFLUORID VARNISH
MDR report key: 8349616
·
Received February 19, 2019
Report
- Report Number
- 8010908-2019-00002
- Event Type
- Injury
- Date Received
- February 19, 2019
- Date of Event
- May 23, 2018
- Report Date
- February 19, 2019
- Manufacturer
- VOCO GMBH
- Product Code
- LBH
- PMA / PMN Number
- K080814
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
COLOPHONY-INTOLERANCES CANNOT BE EXCLUDED. THE INSTRUCTIONS FOR USE CONTAIN APPROPRIATE WARNINGS. [(B)(4)].
Description of Event or Problem · 1
A PATIENT WAS IN FOR AN EXAM AND WAS ALSO TREATED WITH FLUORIDE VARNISH. THE PATIENT CALLED AFTER A WEEK AND HAD A REACTION. SORE LIPS AND LATER ALSO A BIT OF NUMBNESS. THE PATIENT HAS RECOVERED WITHOUT PROBLEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143448 | VOCO PROFLUORID VARNISH | VOCO PROFLUORID VARNISH | LBH | VOCO GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |