MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-03 for VOCO PROFLUORID VARNISH REF 2233 manufactured by Voco Gmbh.
[179420675]
Colophony-intolerances cannot be excluded. The instruction for use contain appropriate warnings.
Patient Sequence No: 1, Text Type: N, H10
[179420676]
The (b)(6) has forwarded to us a user incident report (yellowcard). The patient has had a suspected allergic reaction to/at same time as treatment using this product. They have had no reactions to this product previously. The patient was taking voco profluorid varnish cherry flavour 10ml for: prevention of dental caries. Allergy has completely subsided within 48 hours. Patient attended gp and hospital setting, treated with anti-histamines only, no steroids as patient has perthes, a rare hip condition affecting bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010908-2019-00006 |
| MDR Report Key | 9543409 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-19 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2019-12-12 |
| Date Added to Maude | 2020-01-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-01-03 |
| Catalog Number | REF 2233 |
| Lot Number | 1917468 |
| 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 | 2020-01-03 |