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

Device Problem Increased Sensitivity (2535)

Patient Problems Swelling (2091); Tingling (2171)

Event Date 09/30/2014

Event Type  Injury  

Event Description

Dentist's office called and reported they received a call from a pt who complained of swollen lips and a tingling feeling on her tongue.The pt whitened for approx 1 week, then developed swelling.She stopped for a few days without consulting her dentist.The swelling subsided then she whitened again and the reaction reoccurred after 1 night.She then contacted her dentist.Instructed dental office to advise pt to stop whitening and any future whitening after the symptoms subside to be done without the desensitizer.

Manufacturer Narrative

Likely allergic reaction to the hema desensitizer.

• Brand Name: KOR TEETH DESENSITIZER
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): EVOLVE DENTAL TECHNOLOGIES INC.; irvine CA
• Manufacturer Contact: dina bantle ; 5 vanderbilt; irvine, CA 92618 ; 9497130909
• MDR Report Key: 4193950
• MDR Text Key: 5149813
• Report Number: 3010407924-2014-00015
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• 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: 10/01/2014
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: KOR TOOTH WHITENING
• Patient Outcome(s): Life Threatening