MAUDE Adverse Event Report: VOCO PROFLUORID; VARNISH, CAVITY

Health Effect - Clinical Codes	Erythema (1840); Inflammation (1932); Pain (1994); Local Reaction (2035); Burning Sensation (2146)
Type of Reportable Event	Serious Injury
Event or Problem Description
Painful allergic reaction of the lips and mouth from voco profluoride treatment at dentist.Within seconds of the dental assistant brushing it on, lips burned like they were on fire increasingly and i had her stop putting it on.Lips and mouth turned bright red with flushing and puffiness of face.Around my mouth and corners turned red and were very painfully searing and needed benadryl and hydrocortisone cream to calm it down.The voco company said it was probably the colophony in it.This was at the dentist office.They have the box.

• Brand Name: VOCO PROFLUORID
• Common Device Name: VARNISH, CAVITY
• MDR Report Key: 12275405
• Report Number: MW5102953
• Device Sequence Number: 4728574
• Product Code: LBH
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

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
• Operator of Device: No Information
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): No Information
• Usage of Device: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 58