VENUS DIAMOND FLOW SYR A1 66040354

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-10 for VENUS DIAMOND FLOW SYR A1 66040354 manufactured by Heraeus Kulzer Gmbh.

Event Text Entries

[3863486] This is the first of four reports for one office. Spoke to dental assistant. She said that they noticed air bubbles while extruding. She said that about four pts have returned due to sensitivity and they replaced the restorations. Two for the shade a1 and two for shade a2. She said that the sensitivity resolved and they are doing fine. She said that they cure the vdf for 20 seconds minimum with an led curing light. Please refer mfr report # 9610902-2013-00094.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1925223-2013-00131
MDR Report Key3353264
Date Received2013-09-10
Date of Report2013-08-14
Date Facility Aware2013-08-14
Date Added to Maude2013-09-18
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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 FDA0
Event Location0
Manufacturer Street4315 SOUTH LAFAYETTE BLVD.
Manufacturer CitySOUTH BEND IN 466142517
Manufacturer CountryUS
Manufacturer Postal466142517
Manufacturer G1HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION
Manufacturer Street4315 SOUTH LAFAYETTE BLVD.
Manufacturer CitySOUTH BEND IN 46614251
Manufacturer CountryUS
Manufacturer Postal Code46614 2517
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameVENUS DIAMOND FLOW SYR
Generic NameEBC SEALANT, PIT AND FISSURE, AND CONDI
Product CodeEBC
Date Received2013-09-10
Returned To Mfg2013-09-09
Model NumberA1
Catalog Number66040354
Lot Number010105
Device Expiration Date2016-09-16
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age1 YR
Device Sequence No1
Device Event Key0
ManufacturerHERAEUS KULZER GMBH
Manufacturer AddressWEHRHEIM GM


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-09-10

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