MAUDE Adverse Event Report: GC AMERICA INC. ALIKE 4OZ LIQUID; TEMPORARY CROWN AND BRIDGE RESIN

Catalog Number	340591
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146)
Date of Event	03/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.Unable to reach patient or dentist.
Event or Problem Description
Gc america inc.(gca) received a letter from a patient on 17 mar 2017.The patient had received dental work in a university setting by a dental provider on 07 mar 2017.The patient's mouth began to burn.The dental provider had used the following chemicals: viscostat, henry schein temporary cement remover, vps tray adhesive, and alike liquid monomer.The dental provider put vaseline on the patient's burned lips and gave the patient vaseline to continue putting on their mouth.On (b)(6) 2017, the patient had an appointment with their personal doctor to examine the burns and to check their high blood pressure.The personal doctor prescribed cephalexin to prevent an infection from the burns and silver sulfadiazine to avoid or treat skin infections from the burns.No additional information was obtained.

• Brand Name: ALIKE 4OZ LIQUID
• Common Device Name: TEMPORARY CROWN AND BRIDGE RESIN
• Manufacturer (Section D): GC AMERICA INC.; 3737 w. 127th st.; alsip IL 60803
• MDR Report Key: 6605730
• Report Number: 1410097-2017-00001
• Device Sequence Number: 1089477
• Product Code: EBG
• UDI-Device Identifier: D6583405911
• UDI-Public: D6583405911
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K833261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2017

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 Catalogue Number: 340591
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TEMPORARY CEMENT REMOVER (HENRY SCHEIN); VISCOSTAT; VPS TRAY ADHESIVE
• Outcome Attributed to Adverse Event: Other