MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH RELYX U200 CEMENT; DENTAL CEMENT

Catalog Number 56878

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The product is expected to be returned to 3m for evaluation.If the sample is returned and evaluation results become available, a follow-up report will be submitted.

Event Description

On (b)(6) 2016, a dentist from (b)(6) reported to 3m that a patient was recommended for endodontic treatment.This patient experienced persistent sensitivity (for approximately 2 months) following placement of a crown (manufacturer unknown) using 3m epse relyx u200 cement (also known as relyx unicem 2 cement).

• Brand Name: RELYX U200 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: 5710921
• MDR Text Key: 47090343
• Report Number: 9611385-2016-00007
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K100756
• 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,Followup
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: 56878
• Device Lot Number: 590933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR