EXACTA TEMP *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-03-21 for EXACTA TEMP * manufactured by Exacta Dental Products, Inc..

Event Text Entries

[592550] After performing lengthy but routine dental repair, the pt experienced swelling of mucosal tissue adjacent to material, caused sloughing, and eventually subsided after the use of diprolene. The product was exacta temp-orary-crown and bridge material.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1042337
• MDR Report Key: 831069
• Date Received: 2007-03-21
• Date of Report: 2007-03-21
• Date of Event: 2007-02-05
• Date Added to Maude: 2007-03-28
• 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: DENTIST
• 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: EXACTA TEMP
• Generic Name: *
• Product Code: ELZ
• Date Received: 2007-03-21
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 818410
• Manufacturer: EXACTA DENTAL PRODUCTS, INC.
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2007-03-21