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 02/26/2018

Event Type  Injury  

Manufacturer Narrative

Likely allergic reaction to the hema in the desensitizer.

Event Description

Dentist reported that patient's lips are swollen after whitening.Advised dentist to inform the patient to discontinue use of the kör desensitizer permanently, and if need be, she can see her general practitioner to help with any symptoms.Followed with dental office several times, office did not have patient status to report.

• 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: 7393689
• MDR Text Key: 104219313
• Report Number: 3010407924-2018-00011
• 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: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• 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: 02/26/2018
• 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): Life Threatening
• Patient Age: 62 YR
• Patient Weight: 86