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

Catalog Number 3535

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

Patient Problems Swelling (2091); Tissue Breakdown (2681)

Event Date 09/07/2017

Event Type  Injury  

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 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
• Type of Device: DENTAL CEMENT
• 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: 6906290
• MDR Text Key: 87840169
• Report Number: 3005174370-2017-00047
• Device Sequence Number: 1
• Product Code: EMA
• UDI-Device Identifier: 30605861014015
• UDI-Public: 30605861014015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111185
• 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: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 3535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR