MAUDE Adverse Event Report: MEDICAL PRODUCTS LABORATORIES, INC. DARBY VARNISH

Model Number	9430600
Medical Device Problem Codes	Use of Device Problem (1670); Device Handling Problem (3265)
Health Effect - Clinical Codes	Caustic/Chemical Burns (2549); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Date of Event	03/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Dental assistant got some of the product on the girl's face and she woke up the next morning with a burn mark on her cheek.The parents of the patient contacted an advise nurse and sent pictures of the burn to her doctor for him to review, along with information about the product.The parents were advised to treat it as a 1st or 2nd degree chemical burn and took the advise steps provided by the doctors.The patient's parents are unaware of any known allergies.The female had received varnish treatments previously.The clinical notes stated that she was treated with varnish preciously on (b)(6) 2015.

• Brand Name: DARBY VARNISH
• Common Device Name: VARNISH
• Manufacturer (Section D): MEDICAL PRODUCTS LABORATORIES, INC.; 9990 global road; philadelphia PA 19115
• MDR Report Key: 6513375
• Report Number: 1941138-2017-00001
• Device Sequence Number: 16165971
• Product Code: LBH
• UDI-Device Identifier: 00889813001059
• UDI-Public: 00889813001059
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K040098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2017

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 Assistant
• Device Expiration Date: 09/30/2018
• Device Model Number: 9430600
• Device Catalogue Number: 9430600
• Device Lot Number: 52123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2017
• Initial Report FDA Received Date: 04/21/2017
• 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: 10 YR