COE-SOFT DENTURE RELINE MATERIAL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-17 for COE-SOFT DENTURE RELINE MATERIAL manufactured by G C America.

Event Text Entries

[57982388] After the procedure on (b)(6) 2016, reporter stated that her mouth began to sting a lot. The dentist had however informed her of some pain after the procedure. When she got home, she took the dentures out and ate. Her mouth still hurt while she ate. After eating, she put it back on and decided not to use salt water to rinse her mouth due the pain she felt. Gradually, her tongue began to swell and sting. It's the next day she realized she was having an allergic reaction. Her lips got sore, mouth red, then turned to a blistery rash around her mouth and her head felt as if on fire. She called the dentist but got no feedback from him. Reporter stated that she has been hoping these symptoms will subside but to no avail. A couple of days later, her sinuses were stinging and there was a lot of loose, clear drainage which still oozes out till this moment. Reporter stated that her face is getting better but her lymph nodes, upper lip, and front gums are still swollen and sore and it hurts to speak. Reporter is unhappy that she was not aware of what was put in her mouth as far as the ingredients that make up the material are concerned. She is concerned that the manufacturer still wouldn't release that information to her.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5065490
• MDR Report Key: 6039516
• Date Received: 2016-10-17
• Date of Event: 2016-09-15
• Date Added to Maude: 2016-10-19
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• 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 DENTURE RELINE MATERIAL
• Generic Name: COE-SOFT DENTURE RELINE MATERIAL
• Product Code: EBI
• Date Received: 2016-10-17
• Device Availability: R
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: G C AMERICA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-10-17