VOCO PROFLUORID VARNISH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2019-08-05 for VOCO PROFLUORID VARNISH manufactured by Voco Gmbh.

MAUDE Entry Details

Report Number8010908-2019-00005
MDR Report Key8859039
Report SourceCONSUMER,HEALTH PROFESSIONAL,
Date Received2019-08-05
Date of Report2019-08-05
Date of Event2019-05-03
Date Mfgr Received2019-06-19
Date Added to Maude2019-08-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR MICHAEL CYLL
Manufacturer StreetANTON-FLETTNER-STRASSE 1-3
Manufacturer CityCUXHAVEN, NIEDERSACHSEN 27472
Manufacturer CountryGM
Manufacturer Postal27472
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVOCO PROFLUORID VARNISH
Generic NamePROFLUORID VARNISH
Product CodeLBH
Date Received2019-08-05
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerVOCO GMBH
Manufacturer AddressANTON-FLETTNER-STRASSE 1-3 CUXHAVEN, NIEDERSACHSEN 27472 GM 27472


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-08-05

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