MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-08 for VOCO PROFLUORID VARNISH manufactured by Voco Gmbh.
[61700972]
An investigation of the product in question could not be performed. The product was not returned to us. Lot-number and expiry date are unknown. The case was assigned to the department of complaints and documented. No further measures are planned on this case. Colophony-intolerances cannot be excluded, especially following application to extensive surfaces like this case. The instructions for use contain appropriate warnings. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[61700973]
The (b)(4) agency has received a report from a (b)(6) healthcare provider regarding an incident with voco profluorid varnish. The incident concerns a patient with side effects such as swelling and itching after treatment with profluorid varnish. The medical products agency requests u. S. To submit a vigilance report from the manufacturer to the medical products agency in accordance with (b)(4) regulation. Voco profluorid varnish is marketed in u. S. ;therefore, the event is reportable accordingly 21cfr 803. Incident description received by dentist: dentist treated the patient with fluoride varnish generally, on every tooth on the 30/8. A week later, his mother was at the clinic and told him that the boy had an allergic reaction in the evening/night and reacted with itching/sore/swelling in the mouth and on the lips. The parents could not connect the reaction to anything else but the fluoride varnish. The patient is fully recovered. There is no severe medical implication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010908-2016-00002 |
| MDR Report Key | 6154096 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-08 |
| Date of Report | 2016-12-08 |
| Date of Event | 2016-08-30 |
| Date Mfgr Received | 2016-11-25 |
| Date Added to Maude | 2016-12-08 |
| 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 Phone | 4721719 |
| 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 | 2016-12-08 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization | 2016-12-08 |