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 05/07/2016

Event Type  Injury  

Manufacturer Narrative

Likely allergic reaction to the hema in the desensitizer.

Event Description

Dentist reported on (b)(6) 2016 to inform that her staff member started whitening at-home on (b)(6) 2016 and noticed swelling on (b)(6) 2016.Dentist advised her staff member to stop using the desensitizer, that she was experiencing an allergic reaction, and prescribed benadryl.As of day of report the swelling has subsided.Effected staff member is doing well and continuing with whitening.

• 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: matt carpenter ; 5 vanderbilt; irvine, CA 92618 ; 9497130909
• MDR Report Key: 5934853
• MDR Text Key: 54138324
• Report Number: 3010407924-2016-00017
• 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: Dental Assistant
• Type of Report: Initial
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• 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
• Date Manufacturer Received: 05/13/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 33 YR
• Patient Weight: 64