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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Swelling (2091); Reaction (2414)

Event Date 11/05/2014

Event Type  Injury  

Event Description

Pt experienced swelling of the lips while using kor at home whitening.Dentist suspected the desensitizer.Dentist advised the pt to discontinue whitening and use of the desensitizer indefinitely and the symptoms subsided.

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: 4320490
• MDR Text Key: 15818751
• Report Number: 3010407924-2014-00017
• 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: Dentist
• Type of Report: Initial
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2014
• 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?: No
• Date Manufacturer Received: 11/11/2014
• 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