MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-23 for VOCO PROFLUORID VARNISH manufactured by Voco Gmbh.
[128255588]
Allergic reactions, such as swelling and increased temperature, cannot be excluded in individual cases. The instructions for use contain appropriate warnings. In case of problems, the treatment must be stopped and the fluoride varnish removed. The current condition of the patient is not known. The results of the allergy tests are not available. The patient's reactions were not classified as severe by the dentist. It is unlikely that voco profluorid varnish caused the patient's ongoing discomfort. It is possible that these symptoms are due to intolerance to cetirizine dihydrochloride or other medications. However, it is possible that the use of voco profluorid varnish contributed to the event. In case of doubt, therefore, a reportable event is assumed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[128255589]
Incident description we received from the dentist: "reaction description: patient's mum rang the practice on (b)(6) 2018. She explained the patient had swelling of his lips and face and had a temperature since the varnish had been applied. The ingredients of the varnish were emailed over to mum and discussed thoroughly over the telephone. Mum had made an appointment later in the day to see the gp. The varnish was removed from use. Mum rang us back on (b)(6) 2018. Gp had referred the patient for allergy testing and patient was now taking cetirizine dihydrochloride. Spoke again with mum on (b)(6) 2018. The patient is still unwell and mum said he is not right and his allergies seem to have escalated since the last time we spoke. There was a trip a few weeks ago to a&e when the patient complained his breathing hurt, no diagnosis or further medication was given to the patient. There is now a wheeze similar to an asthma wheeze present. This is "effecting" the patient's sleep and he is tired in the day which is causing his behaviour to change. Mum says he is now naughty and this wasn't how he was before (b)(6). I asked mum if the patient takes any regular medication; mum said no. I asked mum if the patient had received any vaccinations in the last 3 months; mum said the patient had a 3 year booster at the local gp on (b)(6) 2018. An appointment has been made at the hospital for allergy testing next month. Mum has said she will keep us posted. The patient was taking voco fluoride varnish cherry for: dental caries. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010908-2018-00002 |
| MDR Report Key | 8099832 |
| Date Received | 2018-11-23 |
| Date of Report | 2018-11-23 |
| Date of Event | 2018-02-02 |
| Date Added to Maude | 2018-11-23 |
| 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 | 0 |
| Brand Name | VOCO PROFLUORID VARNISH |
| Generic Name | VOCO PROFLUORID VARNISH |
| Product Code | LBH |
| Date Received | 2018-11-23 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Required No Informationntervention | 2018-11-23 |