SILASTIC *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-06-21 for SILASTIC * manufactured by Unk.

MAUDE Entry Details

• Report Number: MW1040986
• MDR Report Key: 781230
• Date Received: 2006-06-21
• Date of Report: 2006-06-21
• Date of Event: 2006-05-01
• Date Added to Maude: 2006-11-16
• 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: SILASTIC
• Generic Name: SILASTIC
• Product Code: KGM
• Date Received: 2006-06-21
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 769010
• Manufacturer: UNK
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2006-06-21