COE-SOFT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-28 for COE-SOFT manufactured by Gc America.

Event Text Entries

[71324050] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5068722
• MDR Report Key: 6442343
• Date Received: 2017-03-28
• Date of Report: 2017-03-27
• Date of Event: 2017-03-27
• Date Added to Maude: 2017-03-29
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: COE-SOFT
• Generic Name: DENTURE, RELINING
• Product Code: EBI
• Date Received: 2017-03-28
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GC AMERICA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-03-28