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

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091); Reaction (2414)

Event Date 09/18/2019

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 fourth 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

It was reported that a patients experienced a reaction to integrity temporary c&b material.The patient broke out in blisters.Magic mouth wash was given to combat the patient's symptoms.The reaction subsided in a few days.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.Retain device was evaluated and found to be within specification.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.

• 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
• MDR Report Key: 9214389
• MDR Text Key: 163148966
• Report Number: 2515379-2019-00031
• Device Sequence Number: 1
• Product Code: EBG
• Combination Product (y/n): N
• PMA/PMN Number: K013674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• 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: 00001332
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/08/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR