MAUDE Adverse Event Report: EVOLVE DENTAL TECHNOLOGIES KOR TEETH DESENSITIZER; AGENT, TOOTH BENDING, RESIN CPC KLE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Reaction (2414); Sensitivity of Teeth (2427)

Event Date 04/02/2014

Event Type  Injury  

Event Description

Dentist's office reported a patient allergic reaction to the desensitizer.Patient experienced a significant allergic response after beginning whitening treatment.Patient has no known allergies, she isn't on any medication and the only medical condition she listed was occasional migraine headaches.She has used chairside and home whitening products in the past but had minimal results accompanied by what she described as 'intense sensitivity in her teeth' and consequently was reluctant to proceed with kor.She was seen for her initial chairside visit (b)(6), she had virtually no sensitivity during the conditioning appointment and there was no indication of any barrier leakage during the procedure after the dam was removed, tissues looked good.Dentist gave her the usual instructions to skip whitening that night and begin the following night.Dentist told her to begin taking ibuprofen for the next 24 hours whether she had sensitivity or not.Dentist emphasized to the patient not to get any desensitizer on the gum tissue for potential sensitivity.Patient contacted dentist the next day and reported extreme sensitivity in her lower front 'teeth'.She claimed to have no sensitivity in her upper teeth or lower posteriors.Patient claimed she didn't realize she was not supposed to whiten that night.Dentist's assumption at the time was that her teeth were sensitive due to her history of sensitivity to whitening and the facts that she had whitened the night of the conditioning appointment.Dentist recommended that she skips that night, continue taking ibuprofen and contact the office in the morning if she continued to have discomfort.When dentist did not hear from her the following day it was presumed that she was feeling better and was able to resume whitening as instructed.Dentist did not hear from her until (b)(6) 2014 when she said had continued sensitivity in her teeth.She had been able to whiten for a night or two at a time, taking breaks in between.Dentist saw her later that day for an exam.There was no indication that she was having actual 'tooth' sensitivity as cold water and air didn't cause any reaction, however she did have minor visible irrigation along the mandibular buccal tissue and papilla's.Dentist gave her vitamin e oil and recommended she take a few days off from whitening until the sensitivity resolved and to be certain to use only a small amount of solution in her trays.Dentist also recommended that she uses mi paste in her trays until she could begin whitening again.She then contacted dentist on (b)(6) 2014 and said she had to see her medical doctor immediately on (b)(6) 2014 due to lip and facial swelling and intense pain.She had no visible lip swelling or lesions in the vestibules on the (b)(6) 2014 and said she had to see her medical doctor immediately on (b)(6) 2014 due to lip and facial swelling and intense pain.She had no visible lip swelling or lesions in the vestibules on the (b)(6) 2014 appointment.Her md told her it was most likely a hema (after looking through her kor kit) and placed her on a medrol pack and triamcinolone acetonide dental cream.She presented back in office on (b)(6) for a follow up check.She was slightly better in terms of the swelling but was still experiencing 45 pain on a 1-5 scale and was noticing swelling in fingertips.

Manufacturer Narrative

Desensitizer is the likely cause of a hema allergic reaction.Advised to stop desensitizer use indefinitely.Other remarks: dentist prescribed her pen vk and percocet to manage her pain in addition to the prednisone and cream her md had her on.

• Brand Name: KOR TEETH DESENSITIZER
• Type of Device: AGENT, TOOTH BENDING, RESIN CPC KLE
• Manufacturer (Section D): EVOLVE DENTAL TECHNOLOGIES; irvine CA
• Manufacturer Contact: dina bantle ; 5 vanderbilt; irvine, CA 92618
• MDR Report Key: 3854871
• MDR Text Key: 18731503
• Report Number: 3010407924-2014-00005
• 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: 04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2014
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 45 YR