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

Catalog Number	66014565
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Event or Problem 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.
Additional 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.Udi related data quality updates only: no udi-pi/ batch number has been provided to kulzer by complainant despite several attempts.

• Brand Name: VENUS FLOW SYR 1 X 1,8G - A3
• Common Device Name: 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
• Report Number: 3005665377-2023-00008
• Device Sequence Number: 15402006
• Product Code: EBF
• UDI-Device Identifier: J014660145650
• UDI-Public: +J014660145650
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K033665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 66014565
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 10/31/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female