MAUDE Adverse Event Report: DENTAL AMALGAM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Tissue Breakdown (2681)

Event Type  Injury  

Event Description

I am allergic to silver and i have o- blood.I'm allergic to a lot of medications.I had dental amalgam fillings as a child.In 2018 my teeth started to decay.Since then i have been having adverse reactions that you posted on your page of medical devices on (b)(6)2020.Also when i breathe on my arms, my arms tingle and break out like really bad reactions.I believe it was made by the mercury, copper, silver, tin, and zinc that is put in the dental amalgam.Fda safety report id # (b)(4).

• Brand Name: DENTAL AMALGAM
• Type of Device: DENTAL AMALGAM
• MDR Report Key: 11976129
• MDR Text Key: 256324588
• Report Number: MW5101814
• 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: 06/07/2021

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Weight: 93