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 10/15/2018

Event Type  Injury  

Manufacturer Narrative

Likely allergic reaction to the hema in the desensitizer.Note: this mdr is submitted late due to an expired public key, which needed renewal for submission.

Event Description

The patient called, stating that she began whitening at home and when she woke up the next day, her lips, gums, and cheeks were swollen.The patient simply stopped whitening for a week before starting up again, utilizing a desensitizer as well.Again, the patient woke up to swollen lips, gums, and cheeks, at which point she called evolve dental.Advised the patient to discontinue using the desensitizer permanently, and if/when she does decide to resume whitening, she needs to make sure to clean her trays very thoroughly with cold water, at which point she could resume whitening again (once she's fully healed and all swelling is gone).We are shipping out one bottle of kör complete desensitizer to replace the bottle the patient began to utilize.Were able to reach the dental office on (b)(6) 2018 and spoke with (b)(6) who confirmed that the patient was using the old kör desensitizer, containing hema.Advised office to notify patient to discontinue use of the desensitizer "indefinetel", as she may be allergic to the hema in the desensitizer.Dental office reported that patient has resumed whitening without utilizing any desensitizer at all and she has had no further issues.

• 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: 8223880
• MDR Text Key: 132294189
• Report Number: 3010407924-2018-00014
• 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: consumer
• Type of Report: Initial
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• 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: 11/12/2018
• 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: 74 YR
• Patient Weight: 77