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

Device Problem Improper Chemical Reaction (2952)

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

Event Date 06/24/2014

Event Type  Injury  

Event Description

Dentist called and said he had a patient who experienced swelling of the lip the morning after teeth whitening.We informed the dentist of the possible allergy to hema in the kor desensitizer and to tell the patient to stop using the desensitizer indefinitely and to stop using all whitening products until the symptoms subside.He said the patient was completely back to normal and was going to start whitening without the desensitizer.

Manufacturer Narrative

Apparent allergic reaction to the hema in the desensitizer.Symptoms disappeared after patient stopped usage.

• Brand Name: KOR TEETH DESENSITIZER
• Type of Device: AGENT, TEETH BONDING, RESIN CPC KLE
• Manufacturer (Section D): EVOLVE DENTAL TECHNOLOGIES; irvine CA
• Manufacturer Contact: dina bantle ; 5 vanderbilt; irvine, CA 92618
• MDR Report Key: 4186025
• MDR Text Key: 5094703
• Report Number: 3010407924-2014-00012
• 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: 06/25/2014

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: 06/25/2014
• Initial Date FDA 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
• Patient Outcome(s): Life Threatening