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

Catalog Number 3525

Device Problems Patient-Device Incompatibility (2682); Compatibility Problem (2960)

Patient Problems Anaphylactic Shock (1703); Irritation (1941); Swelling (2091)

Event Date 04/17/2015

Event Type  Injury  

Event Description

A pt was seen on (b)(6) 2015 for two crown cementation procedures using 3m espe relyx luting plus cement.The pt called the office on the following day (b)(6) to report that she was experiencing a swollen lip and intra-oral irritation; pt was seen at the office and her symptoms were confirmed when the dentist performed an intra-oral exam.The patient's husband contacted the dental office on (b)(6) to report that the previous night (b)(6), he called 911 and an ambulance brought the pt to the emergency room where she was monitored for anaphylactic shock.The er staff administered an antihistamine and provider her with an epipen to take home.The treating dentist spoke to the pt on (b)(6), and the pt reported she was doing better.The pt is currently pursuing allergy testing.Upon 3m espe follow-up (b)(6) 2015, the dentist reported that the has spoken to the pt two weeks earlier and the pt advised that she was symptom free, back to normal, and is doing fine.The pt is still working with her allergist.In addition, the dentist continues to be in contact with the patient's allergist, but no test results were available to date and there are no plans to remove the crowns.

Manufacturer Narrative

The engineering investigation was limited by lack of returned product and lot number info.The product has been thoroughly evaluated for biocompatibility and found to be safe for its intended use.

• Brand Name: RELYX LUTING PLUS CEMENT
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; saint paul MN
• Manufacturer Contact: 2510 conway avenue; saint paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 4787441
• MDR Text Key: 15962877
• Report Number: 3005174370-2015-00033
• 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: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR