AFFORDABLE DENTURES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-06-07 for AFFORDABLE DENTURES manufactured by Affordable Dentures.

Event Text Entries

[871220] Affordable dentures, a national company, specializing in dentures, has made me a set of dentures, that are dysfunctional - can't eat with them. Cannot even wear them without pain. They say i need a soft liner. I've worn dentures for 53 years, without liners or adhesives. I have now received a letter from affordable dentures for me to come in, for implants, to secure my loose lower denture. I have already gone to another dentist, who has made me a set of dentures, that are functional - i can eat popcorn, corn on the cob, snicker bars, peanut m&m's, salad, cole slaw, nothing seems to be unedible. No liners, no adhesives. I submit this is standard operation procedure for affordable dentures. I submit they are providing substandard dentures, on a national scale. Then they want to sell liners, every two months, implants, and other accessorial services, instead of providing functional dentures. Not only did they provide me with substandard dentures, according to my current dentist, they gave me immediate dentures-temporary dentures - instead of permanent dentures i indicated i wanted. In 52 years of wearing dentures, i have never had temporary dentures, i didn't even know such thing existed. Several times for adjustments, that never worked. Dates of use: 2007. Diagnosis or reason for use: no teeth. Event abated after use stopped or dose reduced: yes. Event reappeared after reintroduction: yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5007240
MDR Report Key1058387
Date Received2008-06-07
Date of Report2008-06-07
Date Added to Maude2008-06-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameAFFORDABLE DENTURES
Generic NameDENTURES
Product CodeNSL
Date Received2008-06-07
ID Number865-2197
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key1027467
ManufacturerAFFORDABLE DENTURES
Manufacturer Address4770 WEST BRAOD STREET COLUMBUS OH 43228 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2008-06-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.