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

Catalog Number 3525TK

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/16/2016

Event Type  Injury  

Manufacturer Narrative

The patient's history suggests a known reaction to artificial fingernails.Such a reaction is often consistent with an allergy to acrylates.As sold, relyx luting cement contains methacrylate monomers; many patients who have allergy to acrylates experience a cross-reaction to methacrylates.For this reason, the product instructions for use contain a warning statement to avoid use in patients with known acrylate allergy.

Event Description

On (b)(6) 2016, a (b)(6) female patient reported she experienced an allergic reaction (symptoms of numbness and roughness of tissues on the left side of her mouth accompanied by throat swelling).These symptoms began after (b)(6) 2016, placement of a non-3m crown on tooth #14 using 3m espe relyx luting plus cement.The patient was treated at an emergency room with an injection of benadryl® and released.Several days later, the patient developed what was described as canker sores in the soft tissue adjacent to the crown; a dexamethasone mouth rinse was prescribed and the sores resolved.

• Brand Name: RELYX LUTING PLUS 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: 5797079
• MDR Text Key: 49620229
• Report Number: 3005174370-2016-00073
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 3525TK
• Device Lot Number: N718885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR