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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HERAEUS KULZER GMBH VENUS DIAMOND; MATERIAL, TOOTH SHADE, RESIN

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HERAEUS KULZER GMBH VENUS DIAMOND; MATERIAL, TOOTH SHADE, RESIN Back to Search Results
Catalog Number 66035474
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Burning Sensation (2146); Complaint, Ill-Defined (2331)
Event Date 03/07/2016
Event Type  Injury  
Manufacturer Narrative
As allowed by exemption# e2012008, heraeus kulzer llc (the importer) is submitting the report on behalf of heraeus kulzer gmbh (the manufacturer).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.H3 other text: not returned, no lot number.
 
Event Description
Male patient has vague allergy symptoms since having dental work done in 2016.Undergoing allergy tests.
 
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Brand Name
VENUS DIAMOND
Type of Device
MATERIAL, TOOTH SHADE, RESIN
Manufacturer (Section D)
HERAEUS KULZER GMBH
philipp-reis-strasse 8/13
wehrheim, D-612 73
GM  D-61273
MDR Report Key6671757
MDR Text Key78545954
Report Number9610902-2017-00009
Device Sequence Number1
Product Code EBF
Combination Product (y/n)N
PMA/PMN Number
K073554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 06/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dentist
Device Catalogue Number66035474
Was Device Available for Evaluation? No
Distributor Facility Aware Date06/07/2017
Initial Date Manufacturer Received 06/07/2017
Initial Date FDA Received06/27/2017
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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