FILSHIE CLIPS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-01-23 for FILSHIE CLIPS * manufactured by Avalon Corp..

Event Text Entries

[335373] Add'l info rec'd from rptr 1/31/04: when former pt reported to rptr that they were pregnant, having done the tubal occlusion, rptr knew that they must report the failure. Rptr has subsequently learned that pt indeed is not pregnant, rather it was a misreading of their ultrasound by the radiologist, and that their physician had told pt they were pregnant without benefit of a pregnancy test, which indeed came up negative.
Patient Sequence No: 1, Text Type: D, B5

[342471] Pt had placement of filshie clips. Positive pregnancy test on event date. Pictures reviewed replacement of device, was placed properly.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1030933
• MDR Report Key: 509171
• Date Received: 2004-01-23
• Date of Report: 2004-01-23
• Date of Event: 2004-01-23
• Date Added to Maude: 2004-02-03
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• 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: FILSHIE CLIPS
• Generic Name: TUBAL OCCLUSION DEVICE
• Product Code: HGB
• Date Received: 2004-01-23
• 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: 498127
• Manufacturer: AVALON CORP.
• Manufacturer Address: 185 ALLEN BROOK LANE WILLISTON VT 05495 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-01-23