MAUDE Adverse Event Report: AMALGAM TOOTH FILLINGS, MERCURY FILLINGS, SILVER FILLINGS; DENTAL AMALGAM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Pain (1994); Cognitive Changes (2551)

Event Date 01/01/2020

Event Type  Injury  

Event Description

I had approx 10 amalgam fillings from my youth.I began really struggling with my health (especially fatigue and brain issues) and it was recommended to have them removed by a safe dentist who understands issues with removal.I had them removed in 2019.I am still trying to climb out of the hole to this day.I am otherwise healthy and have always been an athlete.I had one tooth that had hurt on and off that was apparently leaking.The tooth stopped hurting the day after amalgam removal and hasn't hurt since.Please stop forcing kids to put this awful substance in their mouth.I had no choice and have suffered for it being done.

• Brand Name: AMALGAM TOOTH FILLINGS, MERCURY FILLINGS, SILVER FILLINGS
• Type of Device: DENTAL AMALGAM
• MDR Report Key: 12067106
• MDR Text Key: 258722393
• Report Number: MW5102151
• Device Sequence Number: 4
• Product Code: OIV
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/23/2021
• 10 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 42 YR
• Patient Weight: 50