MAUDE Adverse Event Report: AMALGAM; DENTAL AMALGAM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Death (1802); Toxicity (2333)

Event Type  Death  

Event Description

My brother died from mercury amalgam poisoning.Fda safety report id# (b)(4).

• Brand Name: AMALGAM
• Type of Device: DENTAL AMALGAM
• MDR Report Key: 8658062
• MDR Text Key: 146786879
• Report Number: MW5087018
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 05/29/2019

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Disability
• Patient Weight: 90