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

Catalog Number 607064

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Reaction (2414)

Event Type  Injury  

Event Description

In this event it was reported that a pt experienced gingival inflammation after cementation of several veneers with calibra cement, along with other materials.She underwent flap reflection and cleaning with a periodontist to see the possibility of the excess cement.The pt is still experiencing inflammation and is going to see a doctor for allergy testing.

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 dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device was not returned for eval and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: CALIBRA ESTHERIC RESIN CEMENT
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): DENTSPLY CAULK; milford DE
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st; ste 60, sesquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4186109
• MDR Text Key: 5026863
• Report Number: 2515379-2014-00064
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040906
• 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: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 607064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2014
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention