DENTAL ADHESIVE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-22 for DENTAL ADHESIVE * manufactured by *.

Event Text Entries

[16367052] It has dawned on rptr, after changing dental adhesives from fixodent to cvs brand, that there is no indication of the ingredients used in the manufacture of any brand of adhesive. Rptr. Believes that since the product is ingested when it is washed away by one's own saliva and swallowed, the end user should know whether they are using something that might contain a sweetener or any other item they should avoid. Most users are of senior status and can have, for instance, diabetes. There could be a disasterous affect if the adhesive would contain a sugar substance. Rptr is especially concerned because the cvs brand has such a sweet taste.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1027070
• MDR Report Key: 434928
• Date Received: 2002-12-22
• Date of Report: 2002-12-22
• Date Added to Maude: 2003-01-02
• 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: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DENTAL ADHESIVE
• Generic Name: *
• Product Code: KOM
• Date Received: 2002-12-22
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 423881
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-12-22