INSIGHT-TXSONICS, INC. *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-02-13 for INSIGHT-TXSONICS, INC. * manufactured by Western Institutional Review Board.

Event Text Entries

[287857] Reporter was a research subject to evaluate the safety and effectiveness of mr guided focused ultrasound surgery in the treatment of uterine fibroids. As a pt in the study they want to report and disclose the adverse effects that occurred during the procedure to insure that the fda is aware of the potential risks involved with this surgery. 1. Reporter incurred a 2nd and 3rd degree burn on the area of ultra sound penetration. 2. Reporter stated during the surgery that the pain was an "11", and how it radiated from their left hip down their leg to foot. The surgery continued despite their admission of pain and its severity. 3. Post surgery reporter was unable to walk without severe nerve pain from their left hip to foot for over two months. 4. Hospital stated it would take 2-3 years for the majority of their adl's to return to prior activity levels. 5. Reporter continues to have disability to their left hip with pain and musculoskeletal deformities. Reporter is unable to work full-time or walk up inclines without severe stabbing hip pain. 6. As a study participant reporter is unable to receive insurance benefits, and all-medical costs post surgery have been out of their personal finances.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1027552
• MDR Report Key: 443222
• Date Received: 2003-02-13
• Date of Report: 2003-02-13
• Date of Event: 2002-10-15
• Date Added to Maude: 2003-02-21
• 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
• 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: INSIGHT-TXSONICS, INC.
• Generic Name: FOCUSED ULTRASOUND DEVICE
• Product Code: MIK
• Date Received: 2003-02-13
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: WESTERN INSTITUTIONAL REVIEW BOARD
• Manufacturer Address: 3535 7TH AVE., SW OLYMPIA WA 98502 US 98502

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit	2003-02-13