MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS SCOTCHBOND ETCHANT; AGENT, TOOTH BONDING, RESIN CEMENT, DENTAL

Catalog Number 7423

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Sensitivity of Teeth (2427)

Event Type  Injury  

Manufacturer Narrative

3m (b)(4) received this report on august 26, 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.Of this report describes the second device.Manufacturer report numbers 3005174370-2015-00066 and 9611385-2015-00030, describe the first 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 (b)(4) scotchbond universal adhesive, 3m (b)(4) scotchbond etchant and 3m (b)(4) 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: SCOTCHBOND ETCHANT
• Type of Device: AGENT, TOOTH BONDING, RESIN CEMENT, DENTAL
• 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: 5102006
• MDR Text Key: 26716452
• Report Number: 3005174370-2015-00067
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K813180
• 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: 7423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention