MAUDE Adverse Event Report: DENTAL-AMALGAM

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

I was diagnosed with multiple sclerosis and later believed to believe it because my dental amalgam mercury fillings as my identical twin did not have these fillings.This belief was later confirmed by the position statement sent out by the fda on sept, 24, 2020.It stated that caution should be taken in high-risk individuals (genetically - predisposed).This gives more validity between the connection between these mercury fillings and my ms.My twin should not get these fillings as it can unmask his latent ms.Fda safety report id # (b)(4).

• Brand Name: DENTAL-AMALGAM
• Type of Device: DENTAL-AMALGAM
• MDR Report Key: 14548346
• MDR Text Key: 293147610
• Report Number: MW5109994
• Device Sequence Number: 1
• Product Code: OIV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/25/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2022
• Patient Sequence Number: 1
• Treatment: TECHFIDERA - STOPPED AFTER < 1 YEAR OF USE; THE MERCURY REMOVAL PROCESS INVOLVES THE FOLLOWING: ALPHA LIPOIC ACID [TIMED RELEASE], A POWERFUL CHELATOR/ANTI-OXIDANT CAPABLE OF CROSSING THE BLOOD-BRAIN BARRIER AND BINDING TO MERCURY, COQ 10, VITAMINS A, B, C, D, AND E, MSM,SELENIUM, MAGNESIUM, LITHIUM, BORON, MILK THISTLE, TURMERIC, AND ZINC
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian