MAUDE Adverse Event Report: EVOLVE DENTAL TECHNOLOGIES KOR TEETH DESENSITIZER; AGENT, TOOTH BONDING, RESIN CPC

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Ulcer (2274)

Event Date 05/03/2014

Event Type  Injury  

Event Description

Suspected allergic reaction to the hema in kor 5 ml desensitizer.On (b)(6) 2014 pt had minor lip swelling, and discontinued use of kor desensitizer after first application.On (b)(6) 2014, both lips were swollen, and canker sores began to develop on the insides of her lips.On (b)(6) 2014, lips and tongue are more swollen than the previous day, and canker sores remain.On (b)(6) 2014, tongue and lips still swollen, and canker sores have become worse and more painful.On (b)(6) 2014 no improvement, so pt is going to see doctor.As of (b)(6) 2014, pt is on steroids and has improved dramatically.According to the dentist's office, the pt's doctor isn't sure if her allergic reaction was strictly due to the kor desensitizer, as the pt has an overactive immune system, and a number of different/outside factors could have caused her allergic reaction.Pt's swelling has subsided substantially since starting the steroids, and the sores have diminished.

• Brand Name: KOR TEETH DESENSITIZER
• Type of Device: AGENT, TOOTH BONDING, RESIN CPC
• Manufacturer (Section D): EVOLVE DENTAL TECHNOLOGIES; irvine CA
• Manufacturer Contact: dina bantle ; 5 vanderbilt; irvine, CA 92618
• MDR Report Key: 3876407
• MDR Text Key: 15365011
• Report Number: 3010407924-2014-00006
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953405
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening