VIVATEK TREATMENT SYSTEM NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-04-19 for VIVATEK TREATMENT SYSTEM NI manufactured by *.

Event Text Entries

[189345] Consumer is concerned about a medical device that is now an fda approved and effective treatment for disc conditions.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4002991
• MDR Report Key: 329694
• Date Received: 2001-04-19
• Date of Report: 2001-03-01
• Date Added to Maude: 2001-05-03
• 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: VIVATEK TREATMENT SYSTEM
• Generic Name: DISC TREATMENT
• Product Code: LDQ
• Date Received: 2001-04-19
• Model Number: NI
• Catalog Number: NI
• Lot Number: NI
• ID Number: NI
• Device Availability: *
• Implant Flag: N
• Date Removed: I
• Device Sequence No: 1
• Device Event Key: 319059
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2001-04-19