MAUDE Adverse Event Report: DENTSPLY CAULK ENHANCE FINISHING POINT; AGENT, POLISHING, ABRASIVE, ORAL CAVITY

Catalog Number 624065

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/01/2019

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.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

Event Description

It was reported that a patient experienced an allergic reaction after undergoing a restorative procedure with enhance finishing system along with the other products.The patient reported breaking out in blisters on their buccal mucosa.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.Retain device was evaluated and found to be within specification.A dhr review was conducted with no discrepancies noted.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.

• Brand Name: ENHANCE FINISHING POINT
• Type of Device: AGENT, POLISHING, ABRASIVE, ORAL CAVITY
• Manufacturer (Section D): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• MDR Report Key: 9532873
• MDR Text Key: 179621378
• Report Number: 2515379-2019-00033
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• PMA/PMN Number: K872251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,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: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 624065
• Device Lot Number: 524165
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR