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 01/15/2019

Event Type  Injury  

Manufacturer Narrative

Likely allergic reaction to the hema in the desensitizer.

Event Description

Dentist reported that his patient woke up with what appeared to be swollen lips and sores on the inside and corner of her mouth.The patient had only whitened at night twice (utilizing the kör desensitizer with hema) before waking up with the swollen lips and sores.Requested dentist to inform the patient to discontinue use of the kör desensitizer indefinitely.Followed up with dental office on feb.5, 2019, who said the patient's swelling completely dissipated and all sores were gone within 24 hours.

• 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: 8337551
• MDR Text Key: 136108973
• Report Number: 3010407924-2019-00003
• 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: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: Yes
• 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: 01/15/2019
• 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: 25 YR
• Patient Weight: 59