MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH SCOTCHBOND UNIVERSAL ADHESIVE; AGENT, TOOTH BONDING, RESIN

Catalog Number 41258

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Inflammation (1932)

Event Date 02/10/2015

Event Type  Injury  

Event Description

Dentist reported that one of his patients required endodontic treatment on tooth #18, due to pulpitis after a dental treatment involving 3m espe scotchbond universal adhesive.The patient is currently reported as fine.No further details were made available to 3m espe.

Manufacturer Narrative

The engineering investigation of the returned complaint sample showed that it was of intended construction with no extra or missing peaks identified via ftir.

• Brand Name: SCOTCHBOND UNIVERSAL ADHESIVE
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; neuss ; GM
• Manufacturer Contact: carl-schurz-strasse 1; neuss 41453 ; 9815270013
• MDR Report Key: 4768503
• MDR Text Key: 5795734
• Report Number: 9611385-2015-00001
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110302
• 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: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 41258
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other