VAX-D *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-05 for VAX-D * manufactured by *.

Event Text Entries

[21960116] Currently suffering froma herniated disc and spine disease. In order to try and avoid a lumbar fusion, i visited a vax-d center. Doctor assured me he can help decrease my pain and all together avoid a fusion. To my despair, after only 3 sessions starting on july 26th of this year i am now suffering exhuberant pain that is 20 times worse than prior to receiving the vax-d treatment. I am also unable to walk, unable to sit, and unable to work. I am also having difficulty controlling bowel movement. None of the aforementioned symptoms were present prior to receiving the vax-d decompression. The md at the vax-d clinic has been avoiding my phone calls and does not return my messages.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW1036267
MDR Report Key	752063
Date Received	2005-08-05
Date of Report	2005-08-05
Date of Event	2005-07-29
Date Added to Maude	2006-08-21
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	3
Reporter Occupation	PATIENT
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	VAX-D
Generic Name	SPINAL DECOMPRESSION
Product Code	ITH
Date Received	2005-08-05
Model Number	*
Catalog Number	*
Lot Number	*
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	*
Device Age	*
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	739849
Manufacturer	*
Manufacturer Address	* * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention; 2. Deathisabilit	2005-08-05