MAUDE Adverse Event Report: UNKNOWN AMALGAM FILLINGS; DENTAL AMALGAM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Urinary Tract Infection (2120); Immunodeficiency (2156); Fungal Infection (2419); Weight Changes (2607); Unspecified Gastrointestinal Problem (4491)

Event Date 01/03/2020

Event Type  Injury  

Event Description

Metals and mold toxicity.Originated from amalgam fillings.Toxic bucket overflowed, i was full of mercury.Had amalgams since age (b)(6), now (b)(6).Had them removed over the past 8 years.There is no standard procedure for safely removing these either.Your test unit drop down units do not include ug/g so i selected ug/ml in error.The low and high test range were two separate tests to get an accurate measure of the amount of mercury in my body.This is when all of my health issues began, when having the amalgams removed.The mercury was building in my body over the years but the toxic bucket overflowed when they were drilled and removed.Abnormal weight loss pain in unspecified joint other specified nutritional deficiencies other seasonal allergic rhinitis other allergic and dietetic gastroenteritis and colitis other disorders of electrolyte and fluid balance, nec menopausal and female climacteric states immunodeficiency, unspecified contact with and (suspected) exposure to mold (toxic) contact and (suspected) exposure to other hazardous metals chronic fatigue, unspecified candida enteritis urinary tract infection, site not specified.Fda safety report id #:(b)(4).

• Brand Name: AMALGAM FILLINGS
• Type of Device: DENTAL AMALGAM
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 13711891
• MDR Text Key: 287018303
• Report Number: MW5107989
• 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: 03/06/2022

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: 03/08/2022
• Patient Sequence Number: 1
• Treatment: BIOTOXIN BINDER. ; 20 MCG LIOTHYRONINE. ; COMPLETED 20 CHELATIONS. ; REPLENISHING MINERALS LOST.; VARIOUS SUPPLEMENTS.
• Patient Outcome(s): Disability
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White