DRX9000 NON-SURGICAL SPINAL DECOMPRESSION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-21 for DRX9000 NON-SURGICAL SPINAL DECOMPRESSION manufactured by Health Quest.

Event Text Entries

[20753284] Went in for spinal decompression for my back. Bulging disk l3-4. Was led to believe that this treatment would help to lower my pain level so i could sit, stand and drive. It didn't work, had 26 sessions. They said it was fda approved. I had surgery for a disc problem in (b)(6) 2009, l4-5, l5-s1. I have 6 screws, 3 on each side of the problem area. I was found recently that i have another problem with l3-4. I have a very hard time sitting, standing and driving. I take pain meds, norco. When i met dr (b)(6) and his staff from (b)(6), they led me to believe that their spinal decompression machine would help me to alleviate my pain and discomfort. I had to go for 24 treatments, along with adjustments and that it would do the trick. Because i was not getting any relief, dr (b)(6) had me take a week long prescription of prednisone, that helped for 2 weeks, then the pain was right back. A few weeks later, he had me get an epidural, that lasted a week. I have never had the relief that dr (b)(6) and his staff said i would get from the spinal decompression machine. I live on pain meds and live in terrible pain whenever i try to sit at work, sit on my couch, sit in my van or practically sit anywhere. I can't stand for any period of time. I went to all of the treatments that were suggested and actually had to do a few more until the last one which actually hurt to the point where i had to have the machine turned off. All of this treatment cost(b)(6). The insurance doesn't cover it and i had to pay most of it up front and am still paying.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5037433
MDR Report Key3961044
Date Received2014-07-21
Date of Report2014-07-21
Date of Event2014-01-31
Date Added to Maude2014-07-29
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDRX9000 NON-SURGICAL SPINAL DECOMPRESSION
Generic NameDRX9000 NON-SURGICAL SPINAL DECOMPRESSION
Product CodeITH
Date Received2014-07-21
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerHEALTH QUEST
Manufacturer Address24100 DRAKE RD. FARMINGTON HILLS MI 48335 US 48335


Patients

Patient NumberTreatmentOutcomeDate
10 2014-07-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.