SPARC SLING SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-04-24 for SPARC SLING SYSTEM manufactured by American Medical Systems, Inc..

Event Text Entries

[283675] Info received in 2003 indicates a sparc sling system was removed from a pt. No further info indicated. Ams has requested additional info.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2183959-2003-00040
• MDR Report Key: 455989
• Report Source: 05
• Date Received: 2003-04-24
• Date of Report: 2003-04-24
• Date of Event: 2003-04-09
• Date Mfgr Received: 2003-04-09
• Date Added to Maude: 2003-04-29
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: THERESE BOWKER, MDR CONTACT
• Manufacturer Street: 10700 BREN ROAD WEST
• Manufacturer City: MINNETONKA MN 55343
• Manufacturer Country: US
• Manufacturer Postal: 55343
• Manufacturer Phone: 9529306624
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SPARC SLING SYSTEM
• Generic Name: SPARC/OTHER SLING TYPES
• Product Code: FHK
• Date Received: 2003-04-24
• Model Number: NA
• Catalog Number: NA
• Lot Number: NI
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: NA
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: I
• Device Sequence No: 1
• Device Event Key: 444971
• Manufacturer: AMERICAN MEDICAL SYSTEMS, INC.
• Manufacturer Address: 10700 BREN RD., WEST MINNETONKA MN 55343 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2003-04-24