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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
(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.
 
Event Description
Male patient has vague allergy symptoms since having dental work done in 2016. Undergoing allergy tests.
 
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Brand NameVENUS DIAMOND
Type of DeviceMATERIAL, TOOTH SHADE, RESIN
Manufacturer (Section D)
HERAEUS KULZER GMBH
philipp-reis-strasse 8/13
wehrheim, D-612 73
GM D-61273
Manufacturer (Section G)
HERAEUS KULZER GMBH
philipp-reis-strasse 8/13
wehrheim, D-612 73
GM D-61273
Manufacturer Contact
rita rogers
300 heraeus way
south bend, IN 46614
5742995409
MDR Report Key6671757
MDR Text Key78545954
Report Number9610902-2017-00009
Device Sequence Number1
Product Code EBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 06/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2017
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
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date06/07/2017
Event Location No Information
Date Manufacturer Received06/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/27/2017 Patient Sequence Number: 1
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