MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS RELYX LUTING PLUS AUTOMIX CEMENT; DENTAL CEMENT

Catalog Number	3535
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Swelling (2091); Tissue Breakdown (2681)
Date of Event	09/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Engineering investigation was limited due to lack of returned product and lot number information.The 3m subject product has been evaluated for biocompatibility and is safe for intended use.In addition, the instructions for use (ifu) contains precautionary information about potential allergic reaction following oral soft tissue or skin contact with the product.
Event or Problem Description
A dentist reported that a (b)(6) male patient experienced an allergic reaction that included lip swelling and gingival tissue sloughing following use of 3m espe relyx luting plus automix cement to place 6 porcelain-fused-to-metal crowns on (b)(6) 2017.The patient sought medical attention that same evening, at an emergency room, and was treated with iv steroids (unknown) and benadryl.The dentist saw the patient 12 days later and the symptoms had resolved.The denist reported that the cement was overloaded on the crowns and came in contact with the gums and gingival tissue, and he believes that caused the reaction.Latex gloves were also used during the appointment, but it is unknown if latex may have contributed to the symptoms.

• Brand Name: RELYX LUTING PLUS AUTOMIX CEMENT
• Common Device Name: DENTAL CEMENT
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; 2510 conway avenue; st. paul MN 55144 1000
• MDR Report Key: 6906290
• Report Number: 3005174370-2017-00047
• Device Sequence Number: 16484968
• Product Code: EMA
• UDI-Device Identifier: 30605861014015
• UDI-Public: 30605861014015
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Dentist
• Device Catalogue Number: 3535
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2017
• Initial Report FDA Received Date: 09/29/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR