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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); Rash (2033); Burning Sensation (2146); Complaint, Ill-Defined (2331)
Event Type  Injury  
Manufacturer Narrative
This complaint comes from (b)(6). (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.
 
Event Description
This complaint comes from (b)(6). Patient complained of multiple symptoms in face and jaw. Filling material has been replaced with no reduction of symptoms.
 
Manufacturer Narrative
This complaint comes from (b)(6). (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. On (b)(6) 2016 the results of the allergy testing (ltt) excluded venus diamond as causing allergen. Not returned-no lot number.
 
Event Description
This complaint comes from (b)(6). Patient complained of multiple symptoms in face and jaw. Filling material has been replaced with no reduction of symptoms.
 
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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 Key5892835
MDR Text Key52610565
Report Number9610902-2016-00015
Device Sequence Number1
Product Code EBF
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K073554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 07/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2016
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 Date07/25/2016
Event Location No Information
Date Manufacturer Received07/25/2016
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: 08/22/2016 Patient Sequence Number: 1
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