FILSHIE AVM-851 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-15 for FILSHIE AVM-851 * manufactured by Femcare.

Event Text Entries

[20763697] During a tubal ligation, the physician experienced difficulty in closing the filshie clip on the fallopian tubes. The physician chose to cauterize the fallopian tube rather than use the filshie clips.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1216677-2005-00002
• MDR Report Key: 583201
• Date Received: 2005-03-15
• Date of Report: 2005-03-11
• Date of Event: 2005-02-15
• Date Facility Aware: 2005-02-15
• Date Reported to FDA: 2005-03-11
• Date Reported to Mfgr: 2005-03-11
• Date Added to Maude: 2005-03-22
• Event Key: 0
• Report Source Code: Distributor 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: FILSHIE
• Generic Name: FEMALE CONTRACEPTION
• Product Code: HGB
• Date Received: 2005-03-15
• Model Number: AVM-851
• Catalog Number: *
• Lot Number: 01905
• ID Number: *
• Device Expiration Date: 2007-06-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 573031
• Manufacturer: FEMCARE
• Manufacturer Address: UNIT 2A; MILLENUIM EAST PHOENIX CENTRE NOTTINGHAM, UK * NG8 6AR

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2005-03-15