DENTURES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-14 for DENTURES manufactured by .

Event Text Entries

[83043057] Consumer is (b)(6) and it was time for a new set of dentures. She went to (b)(6) which is all professors that practice in an office. Dr. (b)(6) was the dentist that treated her. On tuesday (b)(6), she got fitted for dentures and was told they are like breaking in a new pair of shoes. By the time she got home at the end of the 8 hours, her mouth was burning. She thought it was strange but thought she was just getting adjusted to it. The next day after she took them out her mouth was swollen. The third day, her mouth was blistered, raw and swollen. When she went back the following tuesday the dentist looked at her mouth. The dentures are made from a new material and she was told they give off gases/monomers and there are some people that are allergic to those monomers. The dentist calls for a medical consult. The doctor said he was going to give her a steroid rinse for her mouth. She told him that she's immunocompromised and can't take steroids.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5071648
MDR Report Key	6800987
Date Received	2017-08-14
Date of Report	2017-08-14
Date of Event	2017-08-01
Date Added to Maude	2017-08-17
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
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	DENTURES
Generic Name	DENTURES
Product Code	NSL
Date Received	2017-08-14
Device Availability	N
Device Eval'ed by Mfgr	I
Device Sequence No	1
Device Event Key	0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-08-14