MAUDE Adverse Event Report: GC AMERICA INC. COE-SOFT 5.5 OZ PROFESSIONAL PACKAGE; DENTURE RELINE

Catalog Number	344011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Chest Tightness/Pressure (2463)
Date of Event	03/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.Not returned to manufacturer.
Event or Problem Description
Gc america inc.(gca) received report mw5068722 from fda's medwatch program on 20 apr 2017.The patient was present at a dental office and under the care of a female dentist.When at or shortly after 3 pm, the dentist applied a dental product known as the brand-name "coe-soft" used as a temporary denture liner.The patient experienced the following symptoms: sinus inflammation, adrenaline rush, fast heart rate (pounding heart), throat scratchiness and stiffness with difficulty swallowing, tightness in the chest, and inability to take a full breath.The patient instructed the dentist to call 911 for the allergic reaction.'name withheld' responded because an ambulance was not close enough.The ambulance arrived and transported the patient to a hospital where treatment was started and completed with 50 mg of benadryl by mouth, 40 mg of prednisone by mouth, 10 mg of famotidine by mouth.Symptoms took 4 to 4.5 hours to subside once treatment was started.No additional information was obtained.

• Brand Name: COE-SOFT 5.5 OZ PROFESSIONAL PACKAGE
• Common Device Name: DENTURE RELINE
• Manufacturer (Section D): GC AMERICA INC.; 3737 w. 127th st.; alsip IL 60803
• MDR Report Key: 6605335
• Report Number: 1410097-2017-00002
• Device Sequence Number: 19077827
• Product Code: EBI
• UDI-Device Identifier: D6583440111
• UDI-Public: D6583440111
• Combination Product (Y/N): N
• PMA/510(K) Number: K0770697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• 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: No Information
• Device Catalogue Number: 344011
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2017
• 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: Hospitalization