NEW DENTURES *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-11-26 for NEW DENTURES * manufactured by *.

Event Text Entries

[20926539] Reporter got new dentures. They are defective, upper tight, lower loose. When reporter asked them to fix it, they denied. When reporter argues with them then they agreed to fix but reporter has to pay money out of their pocked to get that done. Rptr feels it is a total rip off. They should fix it at no cost. Reporter can't eat properly now so they're having upset stomach and stomach pain lately.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1030419
• MDR Report Key: 500986
• Date Received: 2003-11-26
• Date of Report: 2003-11-26
• Date of Event: 2003-09-05
• Date Added to Maude: 2003-12-17
• 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NEW DENTURES
• Generic Name: *
• Product Code: EKO
• Date Received: 2003-11-26
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 489757
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-11-26