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U.S. Department of Health and Human Services

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

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GC AMERICA INC. COE-SOFT 5.5 OZ PROFESSIONAL PACKAGE DENTURE RELINE Back to Search Results
Catalog Number 344011
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Chest Tightness/Pressure (2463)
Event Date 03/27/2017
Event Type  Injury  
Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted. Not returned to manufacturer.

 
Event 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.

 
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Brand NameCOE-SOFT 5.5 OZ PROFESSIONAL PACKAGE
Type of DeviceDENTURE RELINE
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 Key6605335
MDR Text Key76447272
Report Number1410097-2017-00002
Device Sequence Number1
Product Code EBI
Combination Product (Y/N)N
PMA/PMN NumberK0770697
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
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 Received06/01/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue Number344011
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2017
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 Initial

Patient TREATMENT DATA
Date Received: 06/01/2017 Patient Sequence Number: 1
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