MAUDE Adverse Event Report: MERCURY SILVER AMALGAM; DENTAL AMALGAM

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

Patient Problems Inflammation (1932); Pain (1994); Swelling/ Edema (4577)

Event Date 05/11/2023

Event Type  Injury  

Event Description

Dentist applied a mercury silver amalgam filing, and after waiting a two week period to recover, that other fillings recently received by the same dentist took to heal, swelling increased along with intense pain tenderness, and a large protrusion on the gum immediately next to the affected tooth.

• Brand Name: MERCURY SILVER AMALGAM
• Type of Device: DENTAL AMALGAM
• MDR Report Key: 17059239
• MDR Text Key: 316616905
• Report Number: MW5118146
• 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: 05/30/2023

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?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2023
• Patient Sequence Number: 1
• Treatment: AMITRIPTYLINE HCL 50 MG; BENADRYL 50MG PRN; CARBAMAZEPINE 200 MG; IBUPROPHIN 400MG PRN; MELATONIN 10MG; ONDANSETRON ODT 4 MG PRN; TOPIRAMATE 50 MG
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White