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

Device Problem Insufficient Information (3190)

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

Event Date 05/30/2014

Event Type  Injury  

Event Description

Pt had what seems to be an allergic reaction to the kor desensitizer.The pt woke up friday morning (b)(6) 2014, apparently suffering from an allergic reaction to something.Pt immediately discontinued with her kor desensitizer and kor whitening gel, and after the swelling of her lips, gums, and tongue did not subside the following day (b)(6) 2014, she went to the doctor and received a shot of steroids.As of (b)(6) 2014, the pt is much improved, and once all fading symptoms of the previous reaction have subsided, she wishes to continue bleaching without the use of the kor desensitizer.

• 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: 3876405
• MDR Text Key: 4594532
• Report Number: 3010407924-2014-00007
• 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: 06/02/2014

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: 06/02/2014
• 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
• Patient Age: 55 YR