FILSHIE AVM-856 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-05-23 for FILSHIE AVM-856 * manufactured by Femcare.

Event Text Entries

[396968] During a tubal ligation, the tip of the applicator broke. The falopian tubes were tied. Pt has no complications.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1216677-2005-00012
• MDR Report Key: 606238
• Date Received: 2005-05-23
• Date of Report: 2005-05-20
• Date of Event: 2005-04-21
• Date Facility Aware: 2005-04-21
• Report Date: 2005-05-20
• Date Reported to FDA: 2005-05-20
• Date Reported to Mfgr: 2005-05-23
• Date Added to Maude: 2005-05-26
• 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: APPLICATOR
• Product Code: HAM
• Date Received: 2005-05-23
• Model Number: AVM-856
• 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: 701383
• Manufacturer: FEMCARE
• Manufacturer Address: * NOTTINGHAM UK
• Baseline Brand Name: CONMED CAUTERY PENCIL AND TIP
• Baseline Model No: DYNJ01200
• Baseline Device Family: CAUT
• Baseline Shelf Life Contained: N
• Baseline Shelf Life [Months]: *
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2005-05-23