MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-15 for VOCO PROFLUORID VARNISH manufactured by Voco Gmbh.
[127214306]
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.
Patient Sequence No: 1, Text Type: N, H10
[127214307]
(b)(6) forwarded to us a report from a healthcare provider regarding an incident with voco profluorid varnish. The incident concerns a patient with side effects after treatment with proflourid varnish. Voco profluorid varnish is marketed in us. Therefore, the event is reportable accordingly 21cfr 803. Incident description we received from dentist: "reaction description: the patient had not been given a local anaesthetic and no dental reason could be found for the allergic reaction. The numbness and swelling were subsiding the next day, but i advised him to see his doctor as i could not prescribe an antihistamine. He mentioned that he was allergic to seafood and has a sort of similar reaction to seafood. Medically significant details: profluorid varnish was applied topically to two teeth at ul56 for sensitivity. Patient returned the next day with a swollen cheek and lip and numbness of the left side of his face. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010908-2018-00001 |
| MDR Report Key | 8073068 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-15 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-09-04 |
| Date Added to Maude | 2018-11-15 |
| 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 |
| 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 | 2018-11-15 |
| 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. Other | 2018-11-15 |