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

Catalog Number 10-1012

Device Problem No Apparent Adverse Event (3189)

Patient Problems Edema (1820); Skin Irritation (2076); Swelling (2091)

Event Date 10/15/2017

Event Type  Injury  

Manufacturer Narrative

Likely allergic reaction to the hema in the desensitizer.

Event Description

Dentist called and said that the patient complained of swollen lower lip and sores.He said from reading his training materials, he suspected the patient was experiencing an allergic reaction to the hema desensitizer.Advised dentist to have the patient stop using the desensitizer.Followed up with dentist on 10-19-2017, he said that the patient's symptoms have disappeared since she stopped using the desensitizer.Dentist stated that patient wishes to resume whitening so he will have her do so without the use of the kör hema desensitizer.Advised that she should take care to thoroughly clean her bleaching trays with cold water and a cotton swab to remove any residual desensitizer from the tray.

• Brand Name: KÖR DESENSITIZER
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): EVOLVE DENTAL TECHNOLOGIES, INC.; 5 vanderbilt; irvine CA 92618
• Manufacturer Contact: lisa fjastad ; 5 vanderbilt; irvine, CA 92618 ; 9497130909
• MDR Report Key: 7022930
• MDR Text Key: 91793139
• Report Number: 3010407924-2017-00025
• 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: other
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 10-1012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Congenital Anomaly; Life Threatening
• Patient Age: 65 YR
• Patient Weight: 66