VENUS FLOW SYR 1 X 1,8G - A3
Received Nov 21, 2023
Report 1821514-2023-00008 · MDR key 18181659
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Headache
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Headache
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
A PATIENT CLAIMS THAT SHE SUFFERS FROM FORGETFULNESS, AMNESIA APHASIA, DIZZINESS, HEADACHES, 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
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. A PATIENT CLAIMS THAT SHE SUFFERS FROM HEADACHES, 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. NO FEEDBACK HAS BEEN PROVIDED FROM THE TREATING DENTIST AFTER MULTIPLE ATTEMPTS. 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. 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: SENSITIVITIES TO THE PRODUCT OR ITS COMPONENTS CANNOT BE COMPLETELY RULED OUT IN INDIVIDUAL CASES. IN CASE OF AN ALLERGY SUSPICION, THE INGREDIENTS SHOULD BE REQUESTED FROM THE MANUFACTURER. IF NEW INFORMATION BECOMES AVAILABLE, WE WILL UPDATE FURTHER.