MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-10-22 for DRX9000 manufactured by Axiom.
[1674594]
I was duped by a local chiropractor that had advertised in our local newspaper about the drx9000. After 10th treatments, i wasn't getting any better and by the 20th treatment, i had to go to the local rehab treatment center because every step i took was extreme pain. Up to this day, i still have a problem laying down and sitting for a little while which i never had a problem with before the treatments with the srx9000. The machine i think is just a modern version of a medival torture device. Dates of use: (b)(6) 2009. Diagnosis or reason for use: pinched nerve - chiropractor diagnosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018327 |
| MDR Report Key | 1913307 |
| Date Received | 2010-10-22 |
| Date of Report | 2010-10-22 |
| Date of Event | 2009-10-19 |
| Date Added to Maude | 2010-12-08 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRX9000 |
| Generic Name | NONE |
| Product Code | ITH |
| Date Received | 2010-10-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AXIOM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-10-22 |