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

Catalog Number 3525

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

Patient Problem Dyspnea (1816)

Event Date 04/06/2017

Event Type  Injury  

Manufacturer Narrative

Engineering investigation was limited due to lack of returned product and lot number information.The cause of the patient's symptoms is unknown; multiple products were used during the dental appointment.This product contains potassium persulfate, which can trigger an allergic respiratory reaction in certain individuals.Also, in the un-cured state, this product contains methacrylate resins which can trigger an allergic reaction in individuals with sensitivities to acrylic-based materials.Information about these potential reactions are already provided in the product instructions for use.

Event Description

On (b)(6) 2017, a dentist reported that a (b)(6) female patient experienced breathing difficulty upon use of 3m espe relyx luting plus cement to seat crown on tooth #3.Just prior to the crown seating, the patient also had a composite restoration procedure performed on tooth #2.Other products used included an anesthetic, a prophy paste, and a non-3m brand composite material.The dental office administered oxygen and called for emergency medical assistance.The paramedic administered the epipen that the patient normally carries.The patient was then taken to the er, was admitted for observation and was discharged the next day.

• 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: 6528540
• MDR Text Key: 73892816
• Report Number: 3005174370-2017-00038
• 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: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 3525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2017
• 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: 46 YR