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

Catalog Number 3535TK

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

Patient Problems Erythema (1840); Itching Sensation (1943); Swelling (2091); Patient Problem/Medical Problem (2688)

Event Date 03/29/2016

Event Type  Injury  

Manufacturer Narrative

One relyx luting plus automix syringe was returned for analysis, lot #n749297, exp.2017-11.Analysis showed that both paste a and paste b extruded as expected.Since there was not enough paste remaining in the returned sample, a retain sample from the same lot was analyzed for set time and was found to be within specification; no other complaints were found for this lot number.The effect of other products used as potentially contributing to the patient's symptoms is unknown.This product contains methacrylate resins which can trigger an allergic reaction in individuals with sensitivities to acrylic-based materials.This product also contains potassium persulfate which can trigger an allergic respiratory reaction in certain individuals.The instructions for use for relyx luting plus automix cement and safety data sheet both contain a warning for potential reaction.

Event Description

A dentist reported a female patient experienced swelling, itchiness and redness of the upper mucosa after placement of four jensen xt zirconia crowns in the maxillary anterior (in areas #6, 7, 8, and 10) using 3m espe relyx luting plus automix.On (b)(6) 2016, 3m espe learned that the patient sought additional medical treatment at a hospital on (b)(6) 2016 for her symptoms, which included a steroid injection and prescription for predinsone.Later the same day, the dentist removed all four crowns and replaced them with provisional acrylic crowns and instructed the patient to continue with the medication prescribed by the physician and to see an allergist.The patient was reported to be improving and asymptomatic.

• 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: 5693155
• MDR Text Key: 46358897
• Report Number: 3005174370-2016-00061
• Device Sequence Number: 1
• Product Code: EMA
• 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: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 3535TK
• Device Lot Number: N749297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention