MAUDE Adverse Event Report: KULZER, LLC VENUS COMPOSITE; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 66007981

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

Patient Problem Complaint, Ill-Defined (2331)

Event Date 02/01/2017

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.

Event Description

This occurred in (b)(6).A (b)(6) year old female had composite filling done in (b)(6), was fine when she left the practice, but at some point (not known) went to her gp complaining of a reaction to something, and the gp requested a list of ingredients of this product.Type of reaction the patient had is unknown.

• Brand Name: VENUS COMPOSITE
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): KULZER, LLC; philipp-reis-strasse 8/13; wehrheim, hessen 61273 ; GM 61273
• Manufacturer (Section G): KULZER, LLC; philipp-reis-strasse 8/13; wehrheim, hessen 61273 ; GM 61273
• Manufacturer Contact: rita rogers ; 4315 south lafayette blvd.; south bend 46614
• MDR Report Key: 6811177
• MDR Text Key: 83294311
• Report Number: 9610902-2017-00013
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K020131
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/17/2017

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 Number: 66007981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/17/2017
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 08/22/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR