MULTIPLE BRANDS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-10-03 for MULTIPLE BRANDS * manufactured by *.

Event Text Entries

[20159443] Consumer believes that dental adhesives should not be considered medical devices and should require lists on ingredients on the labeling. He believes they should be classified as drugs since they are put in the mouth and the ingredients are partially swallowed and absorbed by the skin.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4004241
• MDR Report Key: 772160
• Date Received: 2006-10-03
• Date of Report: 2006-10-03
• Date Added to Maude: 2006-10-25
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• 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: MULTIPLE BRANDS
• Generic Name: DENTAL/DENTURE ADHESIVES
• Product Code: KOM
• Date Received: 2006-10-03
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 759944
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-10-03