VENUS DIAMOND 66035474

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-06-27 for VENUS DIAMOND 66035474 manufactured by Heraeus Kulzer Gmbh.

Event Text Entries

[78545954] (b)(4). Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution. Narrative-device has not been returned and lot number is not known. Analysis of directions for use state: the use of this product is contraindicated in case of known or suspected allergies against (meth) acrylate compounds. Not returned, no lot number.
Patient Sequence No: 1, Text Type: N, H10


[78545955] Male patient has vague allergy symptoms since having dental work done in 2016. Undergoing allergy tests.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610902-2017-00009
MDR Report Key6671757
Report SourceCONSUMER
Date Received2017-06-27
Date of Report2017-06-07
Date of Event2016-03-07
Date Facility Aware2017-06-07
Date Mfgr Received2017-06-07
Date Added to Maude2017-06-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. RITA ROGERS
Manufacturer Street300 HERAEUS WAY
Manufacturer CitySOUTH BEND IN 46614
Manufacturer CountryUS
Manufacturer Postal46614
Manufacturer Phone5742995409
Manufacturer G1HERAEUS KULZER GMBH
Manufacturer StreetPHILIPP-REIS-STRASSE 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 NameMATERIAL, TOOTH SHADE, RESIN
Product CodeEBF
Date Received2017-06-27
Catalog Number66035474
OperatorDENTIST
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHERAEUS KULZER GMBH
Manufacturer AddressPHILIPP-REIS-STRASSE 8/13 WEHRHEIM, D-61273 GM D-61273


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2017-06-27

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