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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GC AMERICA COE-SOFT DENTURE, RELINING

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GC AMERICA COE-SOFT DENTURE, RELINING Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Inflammation (1932); Tachycardia (2095); Complaint, Ill-Defined (2331); Reaction (2414)
Event Date 03/27/2017
Event Type  No Answer Provided  
Event Description

Serious allergic reaction. I, (b)(6) was present at a dental office known as (b)(6) under the care of a female dentist located at (b)(6), when at or shortly after 3pm, the dentist applied a dental product known as the brand - name "coe-soft" used as a temporary denture liner. I immediately 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. I instructed the dentist to call 911 for allergic reaction. (b)(6) responded because an ambulance was not close enough. Ambulance eventually arrived and transported to (b)(6) hospital where treatment was started and completed with 50mg of benadryl by mouth, 40mg of prednisone by mouth, and 10mg of famotidine by mouth. Symptoms took 4 to 4 and a half hours to subside once treatment was started. Seeking follow-up with physician where testing will be requested. How was it taken or used: topical.

 
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Brand NameCOE-SOFT
Type of DeviceDENTURE, RELINING
Manufacturer (Section D)
GC AMERICA
MDR Report Key6442343
MDR Text Key71324050
Report NumberMW5068722
Device Sequence Number1
Product Code EBI
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/27/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/28/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/28/2017 Patient Sequence Number: 1
Treatment
ALBUTEROL NEBS AS NEEDED; BENADRYL AS NEEDED; FAMOTIDINE AS NEEDED; FLONASE AS NEEDED; GAVISCON EXTRA-STRENGTH AS NEEDED.; OTC MEDS: IBUPROFEN AS NEEDED; RX MEDS: PRO-AIR ALBUTEROL INHALER AS NEEDED
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