MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-19 for VOCO PROFLUORID VARNISH manufactured by Voco Gmbh.
[136474786]
Colophony-intolerances cannot be excluded. The instructions for use contain appropriate warnings. [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[136474787]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010908-2019-00002 |
| MDR Report Key | 8349616 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-19 |
| Date of Report | 2019-02-19 |
| Date of Event | 2018-05-23 |
| Date Mfgr Received | 2019-02-15 |
| Date Added to Maude | 2019-02-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR MICHAEL CYLL |
| Manufacturer Street | ANTON-FLETTNER-STRASSE 1-3 |
| Manufacturer City | CUXHAVEN, NIEDERSACHSEN 27472 |
| Manufacturer Country | GM |
| Manufacturer Postal | 27472 |
| Manufacturer G1 | VOCO GMBH |
| Manufacturer Street | ANTON-FLETTNER-STRASSE 1-3 |
| Manufacturer City | CUXHAVEN, NIEDERSACHSEN 27472 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 27472 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VOCO PROFLUORID VARNISH |
| Generic Name | VOCO PROFLUORID VARNISH |
| Product Code | LBH |
| Date Received | 2019-02-19 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VOCO GMBH |
| Manufacturer Address | ANTON-FLETTNER-STRASSE 1-3 CUXHAVEN, NIEDERSACHSEN 27472 GM 27472 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-19 |