MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH 3M ESPE RELYX ULTIMATE; CEMENT, DENTAL

Catalog Number 56892 (DENTAL KIT)

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Post Traumatic Wound Infection (2447)

Event Date 04/09/2014

Event Type  No Answer Provided  

Event Description

On (b)(6) 2014, 3m espe was contacted by a dentist who reported that following usage of the 3m espe products 3m espe scotchbond universal and 3m espe relyx ultimate, a female patients required endodontic treatment to address sensitivity.The dental treatment was done on (b)(6) 2014.Subsequently five teeth were trepaned and devitalized (one tooth at position 34 on (b)(6) 2014, three teeth at positions 42, 41, 33 on (b)(6) 2014.And one tooth at position 31 on (b)(6) 2014).

Manufacturer Narrative

This incident appears to be related to an allergic reaction to the dental products.An epicutane test against the products showed a mild reaction after 72 hours.The 3m espe scotchbond universal and 3m espe relyx ultimate have been accessed for biocompatibility and have been found to be safe for its intended use.The first suspect medical device is described in manufacturer report number 9611385-2014-00011.

• Brand Name: 3M ESPE RELYX ULTIMATE
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; neuss ; GM
• Manufacturer Contact: carl-schurz-strasse 1; neuss 41453 ; 8152700132
• MDR Report Key: 4182114
• MDR Text Key: 5102916
• Report Number: 9611385-2014-00012
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110508
• 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: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: 56892 (DENTAL KIT)
• Device Lot Number: 512586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 70 YR