MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 6029A2B

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Cellulitis (1768); Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Date 10/13/2015

Event Type  Injury  

Manufacturer Narrative

Product was not returned to 3m for analysis and no lot number was provided; therefore product analysis was limited.Based on the limited information available in this case, 3m was not able to establish a causal relationship between the reported symptoms and the use of the 3m product.In addition, it's unknown what role the use of non-3m products may have had in this event.

Event Description

On (b)(6) 2016 3m was notified of a patient who had experienced facial cellulitis following restorative procedure using 3m espe filtek supreme ultra restorative.Upon follow-up with the dental office on june 14, 2016, it was learned that the patient sought treatment in the er and was diagnosed with an infection and was prescribed an antibiotic.It was also reported that other non-3m products were used during the restorative procedure.Current patient status is reported as fine.

• Brand Name: FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; 2510 conway avenue; st. paul MN 55144 1000
• Manufacturer (Section G): 3M ESPE DENTAL PRODUCTS-IRVINE; 2111 mcgaw avenue; irvine CA 92614
• Manufacturer Contact: angie draper ; 2510 conway avenue; st. paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 5740905
• MDR Text Key: 47902413
• Report Number: 3005174370-2016-00064
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 6029A2B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR