MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-15 for VOCO PROFLUORID VARNISH REF 2231 manufactured by Voco Gmbh.
[179421357]
On the basis of the information available,we share the dentist opinion that the patient's symptoms were probably not caused by treatment with profluorid varnish. Vpv contains colophony. Allergic reactions cannot be excluded in individual cases. However, because the patient needed medical intervention and it cannot be excluded that vpv contributed to the incident, we precautionary report the incident to the fda in accordance with 21 cfr 803. Further action are not required.
Patient Sequence No: 1, Text Type: N, H10
[179421358]
Mother of (b)(6)yo female patient, with no known allergies/ no current medical conditions called the dentists office on 10-jan-2020 reporting "an anaphylactic reaction to the varnish" from the cleaning appointment her child had on thursday ((b)(6) 2020). She said the child complained of a sore/ burning throat on the way home. The patient had a typical exam, prophylaxis and vpv was placed. The patient had been treated once prior to this appointment in the office (prophylaxis) without issue. A photo we received on friday (10-jan-2020) afternoon shows swollen lesions in the tonsil/ throat area. No photo was taken of the gingiva, lips, tongue or buccal mucosa. The patient never complained of pain while in the office or as the vpv was placed. There was no fever and no issues breathing. The hygienist/ doctor was unaware of any issue until the following day (friday 10-jan-2020). The mother then reported to the office that the child saw an oral surgeon, who was a neighbor, and he suggest it was a reaction to the vpv. The mother then took the patient to the paediatrician who diagnosed the patient with allergies. The patient was prescribed steroids by the paediatrician. On 14-01-2020 there was a report to the practice staff the brother now presents with the same lesions. The dentist feels this is a viral/ bacterial infection and not associated with the varnish treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010908-2020-00001 |
| MDR Report Key | 9591559 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date of Event | 2020-01-09 |
| Date Added to Maude | 2020-01-15 |
| 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 | PROFLUORID VARNISH |
| Product Code | LBH |
| Date Received | 2020-01-15 |
| Catalog Number | REF 2231 |
| Lot Number | 1814071 |
| Operator | HEALTH PROFESSIONAL |
| 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, 27472 GM 27472 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-15 |