MAUDE Adverse Event Report: GC CORP. FUJI IX GP; CEMENT, DENTAL

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Itching Sensation (1943); Localized Skin Lesion (4542)

Event Date 12/06/2023

Event Type  Injury  

Event Description

Extreme allergy to composite fillings from 3m, and fuji.Patient first experienced itching, and leasions.And then mouth sores that got infected.Several different brands of composite fillings were tried, and symptoms did not improve until her teeth were restored with amalgam fillings.Ref report: mw5150128.

• Brand Name: FUJI IX GP
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): GC CORP.
• MDR Report Key: 18491971
• MDR Text Key: 332910806
• Report Number: MW5150129
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Hospitalization
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White