MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH 3M ESPE SCOTCHBOND UNIVERSAL; DENTAL ADHESIVE

Lot Number 624091

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

This event involved two medical devices, therefore two manufacturer reports are being submitted.Section of this report describes the first device.Section of manufacturer report number 9611385-2016-00015 describes the second device.

Event Description

On november 25, 2016 it was reported to 3m (b)(4) that after a dental treatment on (b)(6) 2016 with our products 3m espe scotchbond universal and 3m espe relyx ultimate a patient started to suffer from pulpitic pain.Subsequently a root channel treatment was performed on (b)(6) 2016.Currently the patient is doing fine.A follow-up interview with the dentist showed, that the crown was attached before with a harvard cement from a competitor, but had to be removed because of decementation.The crown was then attached with 3m espe¿ scotchbond universal and 3m espe relyx ultimate.The reason for the adverse event is highly probably a pulpitic infection caused by leakage after the debonding of the crown.

• Brand Name: 3M ESPE SCOTCHBOND UNIVERSAL
• Type of Device: DENTAL ADHESIVE
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; carl-schurz-strasse 1; neuss, 41453 ; GM 41453
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH-SEEFELD; espe platz; seefeld, 82229 ; GM 82229
• Manufacturer Contact: thomas meindl ; carl-schurz-strasse 1; neuss, 41453 ; GM 41453
• MDR Report Key: 6196859
• MDR Text Key: 63051400
• Report Number: 9611385-2016-00014
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110302
• 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: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 04/01/2018
• Device Lot Number: 624091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR