SPARC URETHRAL SLING *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-30 for SPARC URETHRAL SLING * manufactured by *.

Event Text Entries

[21957198] Pt was diagnosed with stress incontinence and underwent implantation of a sparc urethral sling. Subsequently, pt experienced infection, vaginal erosion, pain, inability to have intercourse, and continued incontinence.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1027106
• MDR Report Key: 435999
• Date Received: 2002-12-30
• Date of Report: 2002-12-30
• Date of Event: 2002-06-12
• Date Added to Maude: 2003-01-07
• 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: 0
• Reporter Occupation: PATIENT
• 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: SPARC URETHRAL SLING
• Generic Name: *
• Product Code: FHK
• Date Received: 2002-12-30
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 424920
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit	2002-12-30