*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-02 for * manufactured by *.

Event Text Entries

[21614536] Pt appears to have experienced an allergic reaction to the beryllium and nickle used to make their dental bridgework as they developed a strong metallic taste in their mouth and the ulceration of their gum line.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003659
• MDR Report Key: 519968
• Date Received: 2004-03-02
• Date of Report: 2004-02-13
• Date Added to Maude: 2004-04-12
• 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: NA
• Generic Name: DENTAL BRIDGEWORK
• Product Code: EJS
• Date Received: 2004-03-02
• Model Number: *
• Catalog Number: *
• Lot Number: NA
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 509051
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-03-02