*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-11-17 for * manufactured by Avalon.

Event Text Entries

[294828] Pt's tubes were tied. Pt became pregnant 2 months later. Pt miscarried in the first week of treatment 4 months later.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1030226
• MDR Report Key: 496378
• Date Received: 2003-11-17
• Date of Report: 2003-11-17
• Date of Event: 2000-05-01
• Date Added to Maude: 2003-11-21
• 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: 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: *
• Generic Name: FILSHIE CLIP
• Product Code: HGB
• Date Received: 2003-11-17
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 485111
• Manufacturer: AVALON
• Manufacturer Address: 6 HURRICANE LANE WILLISTON VT 05495 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-11-17