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

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

Patient Problem Swelling (2091)

Event Date 04/20/2015

Event Type  Injury  

Event Description

After whitening at home for 21 consecutive nights, the patient reported to dr.(b)(6), that 6 times in the last two weeks she has woken up in the morning with swollen lips.The patient said that within an hour or two on those six mornings, the swelling went away, and there was no discomfort (the patient is currently fine).Dr.(b)(6) advised the patient to discontinue use of the kor desensitizer indefinitely, and that after her trays are thoroughly cleaned to ensure that any possible remnants of the kor desensitizer have been removed, she can then continue whitening.After being advised to discontinue use of the kor desensitizer, the patient has had no issues while continuing whitening at home.

Manufacturer Narrative

Likely allergic reaction to the hema in the desensitizer.

• Brand Name: KOR TEETH DESENSITIZER
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): EVOLVE DENTAL TECHNOLOGIES; irvine CA
• Manufacturer Contact: dina bantle ; 5 vanderbilt; irvine, CA 92618 ; 9497130909
• MDR Report Key: 4808820
• MDR Text Key: 5925786
• Report Number: 3010407924-2015-00009
• 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,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/30/2015
• Initial Date FDA Received: 05/29/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 52 YR