MAUDE Adverse Event Report: 3M COMPANY 3M FILTEK; MATERIAL, TOOTH SHADE, RESIN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Discomfort (2330)

Event Date 08/05/2020

Event Type  Injury  

Event Description

I got multiple white composite fillings done to my teeth.I made sure to get bpa free fillings as i was a bit concerned about that.I developed serious rashes on my gums next to where my fillings were placed, and my teeth got hypersensitive.I also felt an overall discomfort.I saw my dentist again, and she replaced all my fillings with silver amalgam fillings, and since getting the silver fillings done, the rashes are pretty much gone, and i also feel significantly better.Fda safety report id# (b)(4).

• Brand Name: 3M FILTEK
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 10605849
• MDR Text Key: 209454346
• Report Number: MW5096948
• Device Sequence Number: 1
• Product Code: EBF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 38 YR
• Patient Weight: 65