MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH RELYX ULTIMATE ADHESIVE RESIN CEMENT; DENTAL CEMENT

Catalog Number 56890

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 09/16/2015

Event Type  Injury  

Manufacturer Narrative

This event involved two medical devices, two manufacturer reports are being submitted.This report describes the first device.Manufacturer report number 9611385-2015-00050 describes the second device.

Event Description

On (b)(6) 2015, 3m was contacted by a dentist to inquire about proper usage of two products: 3m espe scotchbond universal adhesive and 3m espe relyx ultimate cement.During the report, the dentist indicated that some patients have experienced sensitivity which ultimately resulted in root canal treatment.Despite multiple attempts to obtain follow-up information, no additional information was made available regarding either the number of patients involved or the outcome of the cases.

• Brand Name: RELYX ULTIMATE ADHESIVE RESIN CEMENT
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; carl-schurz-strabe 1; neuss, 41453 ; GM 41453
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH-SEEFELD; espe platz; seefeld, D8222 9; GM D82229
• Manufacturer Contact: thomas meindl ; carl-schurz-strabe 1; neuss, 41453 ; GM 41453
• MDR Report Key: 5169436
• MDR Text Key: 29004293
• Report Number: 9611385-2015-00049
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110508
• 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: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 56890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2015
• Initial Date FDA Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention