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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-21 for * manufactured by *.

Event Text Entries

[292890] Pt had dentures repaired in 2002. After dentures replaced they suffered from adhesions to roof of mouth, stomach ulcers and lung damage. According to pt, their attending physician indicated that they should have the dentures tested for the types of adhesive used in repair of dentures. Pt stated they have lost 30 pounds, cannot lie down and they continually "exhibated" and fluids build up in their lungs.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003541
• MDR Report Key: 476251
• Date Received: 2003-07-21
• Date of Report: 2003-06-03
• Date of Event: 2002-02-01
• Date Added to Maude: 2003-08-08
• 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
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: ADHESIVE FOR DENTURES
• Product Code: EBP
• Date Received: 2003-07-21
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 465078
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	2003-07-21