MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS 3M ESPE FILTEK BULK FILL POSTERIOR RESTORATIVE; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 4863B1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 06/30/2017

Event Type  Injury  

Manufacturer Narrative

This event involved two 3m products; therefore, two manufacturer reports are being submitted.This report represents the first product.Manufacturer report 9611385-2017-00009 represents the second product.

Event Description

On (b)(6) 2017, 3m was notified that a (b)(6) female patient required root canal treatment on tooth #28 following a dental treatment with 3m espe filtek bulk fill posterior restorative and 3m espe elipar deep cure-s led curing lite.

• Brand Name: 3M ESPE FILTEK BULK FILL POSTERIOR 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; 2510 conway avenue; st. paul MN 55144 1000
• Manufacturer Contact: angie draper ; 2510 conway avenue; st. paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 6723753
• MDR Text Key: 80377183
• Report Number: 3005174370-2017-00042
• Device Sequence Number: 1
• Product Code: EBF
• UDI-Device Identifier: 30605861000414
• UDI-Public: (01)30605861000414
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 4863B1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR