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

Catalog Number 6029A2B

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Sensitivity of Teeth (2427)

Event Type  Injury  

Manufacturer Narrative

3m espe received this report on (b)(6) 2015 and has attempted to obtain more patient-specific information.Since the dentist was not able to provide the additional information, patient-specific reporting is not possible.Since this event involved three medical devices, three manufacturer reports are being submitted.This report describes the first device.Mfr report numbers 3005174370-2015-00067 and 9611385-2015-00030, describe the second and third device, respectively.

Event Description

On (b)(6) 2015, dentist advised 3m espe that three or four of her patients required endodontic treatment because of severe sensitivity.The sensitivity followed restorative treatment using 3m espe scotchbond universal adhesive, 3m espe scotchbond etchant and 3m espe filtek supreme ultra universal restorative.Because the dentist was unable to provide patient-specific information, this report is being collectively made for all four patients.After the endodontic treatment, the sensitivity resolved in all of the patients.

• 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: 5101990
• MDR Text Key: 26726232
• Report Number: 3005174370-2015-00066
• 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: health professional
• Reporter Occupation: Dentist
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• 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?: Yes
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention