MAUDE Adverse Event Report: AMALGAM MERCURY

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Malaise (2359); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2008

Event Type  Injury  

Event Description

Reporter called to report that in (b)(6) 2008 his son had one tooth number thirteen filled with amalgam mercury by a dentist in (b)(6) and that his son has been ill and disabled ever since.He reports that his son is unable to enjoy life or family; that he used to a varsity tennis player and had an active social life.Reporter states that he has spent over four hundred thousand dollars to find out what is wrong with his son.Reporter states that he was advised to have the filling removed and since removal he has gotten twenty to thirty percent better."no one has been able to help my son get better after this amalgam filling has made him sick and disabled.No one cares about this in the usa.We have been everywhere trying to find out what is wrong; even the (b)(6) could not tell us.".

• Brand Name: AMALGAM MERCURY
• Type of Device: AMALGAM MERCURY
• MDR Report Key: 12954611
• MDR Text Key: 281938546
• Report Number: MW5105878
• 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: 12/03/2021

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 26 YR
• Patient Sex: Male
• Patient Weight: 64 KG