VARIOLINK VENEER 591425AN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-04 for VARIOLINK VENEER 591425AN manufactured by Ivoclar Vivadent Ag.

Event Text Entries

[71907279]
Patient Sequence No: 1, Text Type: N, H10


[71907280] Customer complained that the material did not polymerize properly when used with the bluephase style curing light. Due to a darkening under the crowns (microleakage), the health care professional had to cut off all of the restorations.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612352-2017-00002
MDR Report Key6456204
Date Received2017-04-04
Date of Report2017-03-27
Date Mfgr Received2017-02-14
Date Added to Maude2017-04-04
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 ContactMS. DONNA HARTNETT
Manufacturer Street175 PINEVIEW DRIVE
Manufacturer CityAMHERST NY 14228
Manufacturer CountryUS
Manufacturer Postal14228
Manufacturer Phone7166912260
Manufacturer G1IVOCLAR VIVADENT AG
Manufacturer StreetBENDERERSTRASSE 2
Manufacturer CitySCHAAN, LI 9494
Manufacturer CountryLS
Manufacturer Postal Code9494
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVARIOLINK VENEER
Generic NameMATERIAL, TOOTH SHADE, RESIN
Product CodeEBF
Date Received2017-04-04
Returned To Mfg2017-02-14
Catalog Number591425AN
Lot NumberU33189
OperatorDENTIST
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerIVOCLAR VIVADENT AG
Manufacturer AddressBENDERERSTRASSE 2 SCHAAN, LS 9494 LS 9494


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-04-04

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