MAUDE Adverse Event Report: DENTSPLY CAULK INTEGRITY TEMPORARY CROWN & BRIDGE MATERIAL-CARTRIDGE SYSTEM; CROWN AND BRIDGE, TEMPORARY, RESIN

Catalog Number 666220

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Ulceration (2116); 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.This report is for the second patient.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 four patients experienced adverse reactions after use of integrity c&b material.In all of the cases, the oral tissue was red, inflamed and ulcerated.The patients were treated with cholorhexodine for the inflammation.One of the patients was reported to have an allergy to sulfa.

Manufacturer Narrative

The device was evaluated and found to be within specification.

• Brand Name: INTEGRITY TEMPORARY CROWN & BRIDGE MATERIAL-CARTRIDGE SYSTEM
• 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: 5217433
• MDR Text Key: 30996358
• Report Number: 2515379-2015-00068
• Device Sequence Number: 1
• Product Code: EBG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013674
• 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: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 666220
• Device Lot Number: 150612
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other