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 03/09/2020

Event Type  Injury  

Manufacturer Narrative

Likely allergic reaction to the hema in the desensitizer.

Event Description

Dental office reported that the patient had swollen lip, hives, and sores in her mouth after whitening at home.The symptoms sounded consistent with a hema an allergic reaction from the former kör desensitizer.Inquired if the patient was using the discontinued desensitzer, and dental assistant confirmed that they missed throwing one out when they replaced them with kör complete and she thought it was the hema desensitizer.Desensitizer was also expired.Office had the patient reach out to evolve dental.Patient sent a photo to confirm that it was hema.Advised to discontinue use of the hema desensitizer indefinitely, thoroughly rinse her trays, follow advisement of her md (she had sought medical care due to having several allergies to medications).

• Brand Name: KÖR DESENSITIZER
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): EVOLVE DENTAL TECHNOLOGIES, INC.; 5 vanderbilt; irvine, ca
• MDR Report Key: 9998763
• MDR Text Key: 193353125
• Report Number: 3010407924-2020-00001
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• PMA/PMN Number: K953405
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• 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
• Date Manufacturer Received: 03/16/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 52 YR
• Patient Weight: 61