NOT AVAILABLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-20 for NOT AVAILABLE manufactured by Affordable Dentures.

Event Text Entries

[1289418] Affordable dentures misfitted me with temporary dentures, even after i told them i only wanted one set of dentures, not two. After repeated appointments, they did not make the dentures functional. I could barely eat soup, without pain. They never informed me, that these were temporary dentures. I only found this out, when i went to a new dentist. Refused to make right. I now have highly functional dentures. I can eat anything, including popcorn, apples, nuts, candy, 'corn on the cob', and nothing seems uneatable. All, without any gels or adhesives. Affordable dentures sent me an advertisement, for denture anchors. If they would make decent dentures, there would be no need for anchors, or, two sets of dentures. I have had dentures for over 50 years. Until now, never a temporary denture. Diagnosis or reason for use: eating. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5015268
• MDR Report Key: 1639131
• Date Received: 2010-03-20
• Date of Report: 2010-03-20
• Date Added to Maude: 2010-03-30
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NOT AVAILABLE
• Generic Name: DENTURES
• Product Code: NSL
• Date Received: 2010-03-20
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AFFORDABLE DENTURES
• Manufacturer Address: COLUMBUS OH US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2010-03-20