MAUDE Adverse Event Report: KULZER GMBH VENUS DIAMOND; COMPOSITE RESIN

Catalog Number 66039015

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

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).

Event Description

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.

• Brand Name: VENUS DIAMOND
• Type of Device: COMPOSITE RESIN
• Manufacturer (Section D): KULZER GMBH; philipp-reis-strabe 8/13; wehrheim, D-612 73; GM D-61273
• Manufacturer (Section G): KULZER GMBH; philipp-reis-strabe 8/13; wehrheim, D-612 73; GM D-61273
• Manufacturer Contact: amber brown ; 4315 s. lafayette blvd; south bend, IN 46614 ; 5472995411
• MDR Report Key: 8451395
• MDR Text Key: 139820066
• Report Number: 9610902-2019-00003
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K910263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2019
• Device Catalogue Number: 66039015
• Device Lot Number: K010040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 20 MO
• Event Location: Other
• Date Manufacturer Received: 02/19/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other