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

Device Problem Insufficient Information (3190)

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

Event Date 09/14/2014

Event Type  Injury  

Event Description

A patient emailed the following "has anyone developed a reaction such as swollen lips and inside around lips raw?".Evolve customer service rep emailed back asking her to stop all whitening and contact their dental office.Patient was also instructed to discontinue desensitizer use definitely.Patient indicated she stopped all whitening until the swelling went away.She then resumed whitening without the desensitizer.No more symptoms appeared after whitening resumed without the desensitizer.

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 INC.; irvine CA
• Manufacturer Contact: dina bantle ; 5 vanderbilt; irvine, CA 92618 ; 9497130909
• MDR Report Key: 4193949
• MDR Text Key: 5098224
• Report Number: 3010407924-2014-00014
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• PMA/PMN Number: K953405
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/15/2014

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?: No
• Date Manufacturer Received: 09/15/2014
• 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