MAUDE Adverse Event Report: DENTSPLY CAULK CALIBRA ESTHETIC RESIN CEMENT; DENTAL CEMENT

Catalog Number 607060

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

In this event a pt reported that they had seen a maxillo facial specialist and who referred the pt for allergy testing because the pt's mouth has been very painful since having veneers fitted using calibra cement.Outcome is unk as of this mdr eval.Follow up is not yet complete.

Manufacturer Narrative

While it is unk if the device used in this case caused or contributed to the pt's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependant upon the severity of the individual allergic response and subsequent exposure of the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device is available for eval, though has not been returned as of this report.Eval results will be submitted as they become available.

• Brand Name: CALIBRA ESTHETIC RESIN CEMENT
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): DENTSPLY CAULK; milford DE
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st; ste 60, susquehanna commerce ctr, w; york, PA 17401 ; 7178457511
• MDR Report Key: 4620609
• MDR Text Key: 19800926
• Report Number: 2515379-2015-00017
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/19/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: 607060
• Device Lot Number: 131111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/19/2015
• Initial Date FDA Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other