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

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Swelling (2091)

Event Date 07/21/2014

Event Type  Injury  

Event Description

Patient had an apparent allergic reaction to the kor desensitizer, where her lips and face became swollen, and her eyes even swelled shut.Patient's swelling did not go down after she stopped using the product, and her eyes began to swell shut, and her breathing was affected.She went to her doctor who gave her prednazone, and within 48 hours, the swelling subsided and went away completely.Patient went to see her doctor, who gave her pregazone, and her swelling dissipated and went away within 48 hours.By the time the dentist office called evolve, the patient had already fully recovered from her apparent allergic reaction to the kor desensitizer.

Manufacturer Narrative

(b)(4).Apparent allergic reaction to the hema in the dessitizer.

• Brand Name: KOR TEETH DESENSITIZER
• Type of Device: AGENT, TOOTH BONDING, RESIN CPC KLE
• Manufacturer (Section D): EVOLVE DENTAL TECHNOLOGIES; irvine CA
• Manufacturer Contact: dina bantle ; 5 vanderbilt; irvine, CA 92618
• MDR Report Key: 4186012
• MDR Text Key: 5023788
• Report Number: 3010407924-2014-00013
• 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: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 07/31/2014
• Initial Date FDA Received: 10/01/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 73 YR