MAUDE Adverse Event Report: DENTAL AMALGAMS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Fatigue (1849); Anxiety (2328); Malaise (2359); Depression (2361); Cognitive Changes (2551); Confusion/ Disorientation (2553); Taste Disorder (4422)

Event Date 03/21/2021

Event Type  Injury  

Event Description

There is no specific date the problem occurred, but is ongoing and worsening.I have had mercury amalgam dental fillings from childhood, and i now have 5.My last one was put in at the age of (b)(6), while pregnant with my first child.I have bruxism and my jaw clenches/ grinds my teeth daily.When this happens i can experience a bitter metallic taste and i become sick and unable to function with the activities of daily life.I suffer from chronic fatigue which can debilitate me for two weeks at a time, worsening cognitive function in which i cannot remember important things, focus, concentrate, or sometimes complete a sentence.I am (b)(6) years old.I suffer from extreme depression, anxiety, mood disorders, and have problems digesting any type of foods.Teeth #s 2, 15, 18, 31, 32.Fda safety report id # (b)(4).

• Brand Name: DENTAL AMALGAMS
• Type of Device: DENTAL AMALGAMS
• MDR Report Key: 11562595
• MDR Text Key: 242451674
• Report Number: MW5100231
• Device Sequence Number: 1
• Product Code: OIV
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 03/21/2021
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 39 YR
• Patient Weight: 58