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

Catalog Number 340591

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.Unable to reach patient or dentist.

Event 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
• Type of Device: TEMPORARY CROWN AND BRIDGE RESIN
• Manufacturer (Section D): GC AMERICA INC.; 3737 w. 127th st.; alsip IL 60803
• Manufacturer (Section G): GC AMERICA INC.; 3737 w. 127th st.; alsip IL 60803
• Manufacturer Contact: mark heiss ; 3737 w. 127th st.; alsip, IL 60803 ; 7089263090
• MDR Report Key: 6605730
• MDR Text Key: 76450029
• Report Number: 1410097-2017-00001
• Device Sequence Number: 1
• Product Code: EBG
• UDI-Device Identifier: D6583405911
• UDI-Public: D6583405911
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 340591
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: TEMPORARY CEMENT REMOVER (HENRY SCHEIN); VISCOSTAT; VPS TRAY ADHESIVE
• Patient Outcome(s): Other