CURAFIL *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-02-02 for CURAFIL * manufactured by *.

Event Text Entries

[484900] We have had numerous reports (5-10) of curafil causing stinging in the wound bed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1038864
• MDR Report Key: 712893
• Date Received: 2006-02-02
• Date Added to Maude: 2006-05-15
• 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: PHARMACIST
• 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: CURAFIL
• Generic Name: *
• Product Code: MGQ
• Date Received: 2006-02-02
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 701957
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2006-02-02