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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Swelling (2091); Reaction (2414)

Event Date 04/26/2013

Event Type  Injury  

Event Description

On (b)(6) 2014, 3m espe was informed of a potential reaction that occurred in a female patient who received dental treatments using 3m espe relyx luting cement.The first treatment was done on (b)(6) 2013.After this initial treatment, the patient suffered from swelling in mouth and on the lips, which were reported to have lasted for approximately three months.A second treatment was done using the same product on (b)(6) 2013.According to the patient, she experienced severe neck swelling and swelling at the right side of the jaw after the second treatment.Because of this, she sought medical attention in a hospital, where she was admitted for three days.No information on medical treatments provided to the patient for either the first or second reaction were made available to 3m espe.Since the second reaction, the patient reports that she has suffered from a sore throat from time to time and approximately one year later, she got a rash on her back, which she believes is also related to the dental treatment.

Manufacturer Narrative

The product wasn't returned to 3m espe and the lot-no.Is not known.Therefore, no further analysis on the product or retained sample could be done.The 3m espe has no other reports or reactions such as this.At this time, it remains unclear as to what agent(s) is (are) responsible for the reported reactions.The dentist is not sure that the dental treatment caused the symptoms and describes the patient as having multiple allergies.The patient herself stated that she underwent several examinations and the results were diverse.Several of the attending physicians didn't see a correlation between the symptoms and the dental treatment.One allergist found that the patient reacts to the dental cement, but details as to the nature of the test and results were not made available to 3m espe.This product has been assessed for biocompatibility by a board-certified toxicologist and has been found to be safe for its intended use using international biocompatibility standards.

• Brand Name: RELYX LUTING CEMENT
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; saint paul MN
• Manufacturer Contact: 2510 conway avenue; saint paul, MN 55144 ; 6517331179
• MDR Report Key: 4340338
• MDR Text Key: 5176124
• Report Number: 3005174370-2014-00038
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K022476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 53 YR