MAUDE Adverse Event Report: MEDICAL PRODUCTS LABORATORIES, INC. DURAFLOR HALO 5% VARNISH

Model Number	1030-WB32
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Diarrhea (1811); Headache (1880); Constipation (3274)
Date of Event	05/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product not returned for evaluation.
Event or Problem Description
A child had a duraflor halo treatment.Later that day the child experienced diarrhea and headaches.Parent administered tylenol.This was the first time that the patient in question used this product.The patient is allergic to soy, she is dairy intolerant, and has coeliac.

• Brand Name: DURAFLOR HALO 5% VARNISH
• Common Device Name: VARNISH
• Manufacturer (Section D): MEDICAL PRODUCTS LABORATORIES, INC.; 9990 global road; philadelphia PA 19115
• MDR Report Key: 6604514
• Report Number: 1941138-2017-00002
• Device Sequence Number: 1010155
• Product Code: LBH
• UDI-Device Identifier: 00686864026662
• UDI-Public: 00686864026662
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/30/2017

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: Dentist
• Device Model Number: 1030-WB32
• Device Catalogue Number: 1030-WB32
• Device Lot Number: 53156
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2017
• Initial Report FDA Received Date: 06/01/2017
• 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: 9 YR