QUANTUM O8XERROID *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-10 for QUANTUM O8XERROID * manufactured by Unk.

Event Text Entries

[321609] Complaint was introduced to this device by a friend. It is thought that the device scans the body and detech abnormalties and then sends in radiowaves to promote healing. The complaint suffered a broken rib in the past. After the first session, for up t 2 hours they felt the effects of the device which included insomnia, discomfort, their toes were curled up and felt as if pt had been electricuted. "their body lit up like a bulb". They felt energized. Then their muscles became weak. They were told they got too much energy and had to stay for 2 days at home. They felt as if an electric field surrounded them. They felt worse anytime they came close to the mouse of a computer and the computer itself. The same thing goes for a cell phone. They could barely walk, had pressure in the chest and at times gasps for breath. Pt had an mri done in 2001 - result was normal.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1029100
• MDR Report Key: 474041
• Date Received: 2003-07-10
• Date of Report: 2003-07-10
• Date of Event: 2001-10-10
• Date Added to Maude: 2003-07-29
• 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: QUANTUM O8XERROID
• Generic Name: LAP TOP COMPUTER OXCI
• Product Code: JAM
• Date Received: 2003-07-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 462894
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-07-10