QXEI-SEIO *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-09 for QXEI-SEIO * manufactured by *.

Event Text Entries

[383367] Rptr feels bio-feedback machines are probably health fraud. Claim to analyze over 8000 body functions. May not have device registration listing.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003817
• MDR Report Key: 561238
• Date Received: 2004-07-09
• Date of Report: 2004-06-10
• Date Added to Maude: 2004-12-27
• 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: 3
• 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: QXEI-SEIO
• Generic Name: BIO-FEEDBACK
• Product Code: HCC
• Date Received: 2004-07-09
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 550942
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-07-09