MAUDE Adverse Event Report: DENTAL AMALGAM FILLINGS

Device Problem Environmental Compatibility Problem (2929)

Patient Problems Itching Sensation (1943); Malaise (2359)

Event Date 01/23/2023

Event Type  Injury  

Event Description

Laboratory elisa kit was used and all products were placed in a biohazard bin in the laboratory.That day and the following days increased illness and gold crown itching until bins were removed.Kits contain sodium azide.Although kits contained a very small amount reactions occurred with acids and other chemicals in the biohazard bins, as well as with metal crown and fillings in mouth.Which became compromised and are causing me significant health issues.Gold crown which i still have, and sodium azide in laboratory product.Most dentistry and all laborator.

• Brand Name: DENTAL AMALGAM FILLINGS
• Type of Device: DENTAL AMALGAM
• MDR Report Key: 17119438
• MDR Text Key: 317147512
• Report Number: MW5118362
• Device Sequence Number: 1
• Product Code: OIV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/08/2023

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2023
• Patient Sequence Number: 1
• Treatment: PRENATAL VITAMIN
• Patient Outcome(s): Disability; Other; Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 45 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian, White