MAUDE Adverse Event Report: KULZER GMBH VENUS DIAMOND PLT REFILL, SHADE A3; COMPOSITE RESIN

Catalog Number 66039011

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

Patient Problem Sensitivity of Teeth (2427)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Patient allergy testing indicated an allergy to methacrylate.Venus diamond composite does contain methacrylate compounds.Based on the allergy test results, dentist replaced the restoration with a glass ionomer cement as a permanent solution.We recommend that in patients with a suspected allergy to the product or information in the history of hypersensitivity to any (dental) materials should undergo an allergy test on the product before use.In patients with known allergies to one or more ingredients of the product (allergy pass), similar substances in the same class of substances or dental products it can not be excluded that undesirable side effects in individual cases may occur.(b)(4).

Event Description

Patient had a composite filling done using venus diamond and had post op sensitivity that did not resolve.Patient had several allergy tests performed by a dermatologist and it was indicated the patient had an allergy to methacrylate.

• Brand Name: VENUS DIAMOND PLT REFILL, SHADE A3
• 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: 8460701
• MDR Text Key: 140192038
• Report Number: 9610902-2019-00002
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K910263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2019

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: Health Professional
• Device Catalogue Number: 66039011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/21/2019
• Initial Date FDA Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other