DENTEK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-10-28 for DENTEK * manufactured by *.

Event Text Entries

[255438] Pt used dentek - a temporary dental cement to secure a bridge that fell off until they could get to the dentist. Now, almost 5 mos later it is still secure and shows no sign of working loose. The dentist can not guarantee that he won't break the bridge pulling it off.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1026569
• MDR Report Key: 425280
• Date Received: 2002-10-28
• Date of Report: 2002-10-28
• Date of Event: 2002-06-15
• Date Added to Maude: 2002-11-04
• 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: DENTEK
• Generic Name: THIN SET CROWN CEMENT
• Product Code: EMB
• Date Received: 2002-10-28
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 414331
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-10-28