MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-03 for VOCO PROFLUORID VARNISH manufactured by Voco Gmbh.
[143970331]
According to our recommendations in the instructions for use, a dosage of 0. 25ml vpv is unproblematic for a complete set of teeth in children. The fluoride content of a single dose is well below the probably toxic dose of 5mg per kg body weight. According to the dentist, about half of a 0. 4 ml sd was used for the treatment. In our evaluation, fluoride poisoning can be ruled out at this dose.
Patient Sequence No: 1, Text Type: N, H10
[143970332]
A dentist received a call from a parent on monday stating that their child had fluoride poisoning after having fluoride varnish applied to their teeth. The child had been seen for a prophylaxis appointment on friday. The child had nausea, severe vomiting and foot numbness that started friday and lasted over the weekend. The child was seen by the local emergency department and both the emergency department and poison control advised the parent that the child's vomiting was due to acute fluoride poisoning from fluoride varnish application.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010908-2019-00004 |
| MDR Report Key | 8577606 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-03 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-04-10 |
| Date Added to Maude | 2019-05-03 |
| 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 | 2019-05-03 |
| 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 | 2019-05-03 |