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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

A follow-up interview by 3m showed a high probability that disregard of the instructions for use may have led to these adverse events.The dentist appears to have overdried during the application, which subsequently may have resulted in the pulpitic sensitivities.

Event Description

On (b)(6) 2016, it was reported to 3m that a dentist had several cases of sensitivity that led to root canal treatment following dental treatment with 3m espe filtek supreme xte universal restorative (also known as filtek supreme ultra universal restorative).The dentist didn't provide any further information about the number of patients involved or the number of root canals performed.

• Brand Name: 3M ESPE 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; 2510 conway avenue; st. paul MN 55144 1000
• Manufacturer Contact: angie draper ; 2510 conway avenue; st. paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 6205110
• MDR Text Key: 63310545
• Report Number: 3005174370-2016-00160
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K083610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other