MAUDE Adverse Event Report: DENTAL AMALGAM

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

Patient Problems Headache (1880); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/28/2015

Event Type  Injury  

Event Description

I had a cavity filled and incidentally the dentist had to remove an amalgam filling that was there to put in a larger composite filling.I had a migraine for 9 days after this and subsequently was diagnosed with myasthenia gravis after experiencing a droopy eyelid soon after the procedure.I believe mercury exposure from the dental amalgam removal triggered myasthenia gravis.

• Brand Name: DENTAL AMALGAM
• Type of Device: DENTAL AMALGAM
• MDR Report Key: 11562524
• MDR Text Key: 242451908
• Report Number: MW5100227
• Device Sequence Number: 1
• Product Code: EFD
• 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: 03/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 38 YR
• Patient Weight: 53