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 04/22/2018

Event Type  Injury  

Manufacturer Narrative

Likely allergic reaction to the hema in the desensitizer.

Event Description

Dentist reported that his patient came in for an in-office whitening only treatment on thursday ((b)(6) 2018).The patient did not whiten or desensitize at home, however a few days later, the patient's lips began to swell, and he contacted the dentist on (b)(6) 2018.Advised the dentist to instruct patient to permanently discontinue any use of the kör desensitizer (if he is planning on whitening at home).Also, i informed dentist to advise the patient to visit his general practitioner if need be to help with any symptoms or inflammation.We also shipped out one bottle of in-office kör complete desensitizer at no charge, which he could use going forward.Followed up with dental assistant, who report the patient returned to normal within 48 hours (all swelling had subsided).

• 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: 7546855
• MDR Text Key: 109356055
• Report Number: 3010407924-2018-00013
• 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: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• 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: 04/23/2018
• 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: 54 YR
• Patient Weight: 91