MAUDE Adverse Event Report: DENTSPLY CAULK INTEGRITY MULTI-CURE TEMPORARY CROWN AND BRIDGE MATERIAL; CROWN AND BRIDGE, TEMPORARY, RESIN

Catalog Number 666670

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Swelling (2091); Burning Sensation (2146); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

While it is unknown if the device used in this case caused or contributed to the patient'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 is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it was reported that a patient experienced an allergic reaction after undergoing a dental procedure with integrity multi cure as one of the materials.The symptoms reported included redness, swelling and a burning sensation.The patient was given benadryl and an anti-inflammatory medication as a result of the symptoms which ultimately subsided.

Manufacturer Narrative

Evaluation found the device expired in march 2016.

• Brand Name: INTEGRITY MULTI-CURE TEMPORARY CROWN AND BRIDGE MATERIAL
• Type of Device: CROWN AND BRIDGE, TEMPORARY, RESIN
• Manufacturer (Section D): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• Manufacturer (Section G): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 6730133
• MDR Text Key: 80618576
• Report Number: 2515379-2017-00012
• Device Sequence Number: 1
• Product Code: EBG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 666670
• Device Lot Number: 1405061
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention