MAUDE Adverse Event Report: YOUNG DENTAL MANUFACTURING I, LLC VARNISH PEN - ASSORTED

Model Number	295782
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Rash (2033); Local Reaction (2035)
Date of Event	04/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient returned for a follow up appointment after her hygiene appointment a week before.Following the appointment, she broke out in sores on the inside of her lips and thinks it is due to the varnish pen.She hasn't had varnish used for over 2 years and has a known history of latex/rubber allergy.The varnish pen was used on her, which was the only new thing used.All other products used have been used on her before.The patient is female in her (b)(6) and has been taking benadryl to treat the sores.The sores were still present during the follow up appointment.The varnish pen is comprised of varnish, an aluminum tube, and plastic.There is no known presence of latex in the makeup of these parts.There is no evidence that suggests the possible reaction was due to the varnish pen.Benadryl was used to reduce the effects of the possible allergic reaction that occured after the hygiene appointment.It has not been concluded that impairment or permanent damage could have occurred if medication had not been used.However, since an additional precaution was used, we believe the event is reportable.This event did not result in serious injury to the patient.

• Brand Name: VARNISH PEN - ASSORTED
• Common Device Name: VARNISH
• Manufacturer (Section D): YOUNG DENTAL MANUFACTURING I, LLC; 13705 shoreline court east; earth city MO 63045
• MDR Report Key: 7512257
• Report Number: 1941138-2018-00001
• Device Sequence Number: 1528739
• Product Code: LBH
• UDI-Device Identifier: 10302732957827
• UDI-Public: 10302732957827
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K153334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Dental Hygienist
• Type of Report: Initial
• Report Date (Section B): 05/14/2018

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: Dental Hygienist
• Device Model Number: 295782
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR