VENUS DIAMOND 66039015

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-26 for VENUS DIAMOND 66039015 manufactured by Kulzer Gmbh.

Event Text Entries

[139820066] The allergy testing that was conducted, concluded that the patient tested negative for (meth) acrylate compound allergies. However, the test did not include tcd-di-hea. Per the global safety manager of kulzer, it is very likely that with the patient having negative reactions to the afore mentioned (meth) acrylates, this is likely also true for the tcd-di-hea. However likely this may be, it cannot concretely rule out that the symptoms experienced were not cause by the venus diamond composite or the composite material did not contribute to the patient reaction. This incident is being reported out of an abundance of caution and to maintain compliance with 21 cfr 803. (b)(4). This incident occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[139820067] Patient experienced strong burning sensation in the mouth. She also reported dryness of the mouth and stated the use of artificial saliva provides relief from the symptoms.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610902-2019-00003
MDR Report Key8451395
Report SourceHEALTH PROFESSIONAL
Date Received2019-03-26
Date of Report2019-03-20
Date Mfgr Received2019-02-19
Date Added to Maude2019-03-26
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 ContactMRS AMBER BROWN
Manufacturer Street4315 S. LAFAYETTE BLVD
Manufacturer CitySOUTH BEND IN 46614
Manufacturer CountryUS
Manufacturer Postal46614
Manufacturer Phone5472995411
Manufacturer G1KULZER GMBH
Manufacturer StreetPHILIPP-REIS-STRABE 8/13
Manufacturer CityWEHRHEIM, D-61273
Manufacturer CountryGM
Manufacturer Postal CodeD-61273
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVENUS DIAMOND
Generic NameCOMPOSITE RESIN
Product CodeEBF
Date Received2019-03-26
Catalog Number66039015
Lot NumberK010040
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age20 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerKULZER GMBH
Manufacturer AddressPHILIPP-REIS-STRABE 8/13 WEHRHEIM, D-61273 GM D-61273


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-03-26

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