MAUDE Adverse Event Report: UNKNOWN AMALGAM FILLINGS; DENTAL AMALGAM

Patient Problems Twitching (2172); Dysphasia (2195); Shaking/Tremors (2515)

Event Date 02/16/2014

Event Type  Injury  

Event Description

(b)(6) health put four amalgam fillings in my mouth which is causing side effects the side effects are tremors and eye blinking and speech problems i already had a speech problem and a tic disorder but due to the fact that i have amalgams in my mouth my speech is worse and my tics are worse and i don't remember the date i got my fillings done at (b)(6) health on (b)(6).The date i put down is a estimate date.I only had dental x-rays done at (b)(6) health.(b)(6) health, (b)(6).Reference reports: mw5147510, mw5147511, mw5147512.

• Brand Name: AMALGAM FILLINGS
• Type of Device: DENTAL AMALGAM
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18040191
• MDR Text Key: 327238876
• Report Number: MW5147509
• 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: 10/18/2023

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?: No
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2023
• Patient Sequence Number: 1
• Treatment: CLONIDINE.; MEDICAL MARIJUANA.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American