MAUDE Adverse Event Report: KULZER GMBH - HQ VENUS FLOW SYR 1 X 1,8G - A3; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 66014565

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

Patient Problems Headache (1880); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

A patient claims that she suffers from headache, amnesic aphasia, forgetfulness, shaking, and stomach issues after a venus flow composite filling was placed.She has seen 3 neurologists, had an mrt, a gastroscopy and blood drawn.Nothing was found during these examinations.Therefore, she expects that the symptoms are caused from venus flow filling.No feedback has been provided from the treating dentist after multiple attempts.

Manufacturer Narrative

Kulzer recommended that the patient see an allergist, general practitioner and her dentist regarding her concerns.It is unknown at this time if and when allergy testing will be conducted.The allegation is the first of its kind to date.These reported symptoms are likely not caused by the product venus flow but out of an abundance of caution we will report this incident.As stated in the ifu sensitivity to the product or its components cannot be completely ruled out in individual cases: "contraindications: the use of this product is contraindicated in case of known or suspected allergies against components of this product.Potential side effects: this product or one of its components may in particular cases cause hypersensitive reactions." if new information become available, we will update further.This incident is reportable according to 21 cfr 803.The fda defines this as a serious injury (21 cfr sec.803.3) the incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.

• Brand Name: VENUS FLOW SYR 1 X 1,8G - A3
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): KULZER GMBH - HQ; leipziger strasse 2; hanau, hesse 63450 ,; GM 63450,
• Manufacturer (Section G): KULZER GMBH - WEHRHEIM; philipp-reis-strasse 8/13; wehrheim, hesse 61273 ; GM 61273
• Manufacturer Contact: matthias hartmann ; leipziger strasse 2; hanau, hesse 63450 ; GM 63450
• MDR Report Key: 18180280
• MDR Text Key: 328610790
• Report Number: 3005665377-2023-00008
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K033665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66014565
• Date Manufacturer Received: 10/24/2023
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female