MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-07 for NEUROGENX 4000PRO manufactured by .
[16176078]
Was treated by a podiatrist for cidp (a type of peripheral neuropathy) with a neurogenx 4000 pro. The stem part of the treatment has resulted in a bad case of chronic tendonitis on the instep of my left foot. I initially had a problem with this condition on both feet after the treatment. I complained to dr (b)(6), and he prescribed naprozen 500mg 2x/day. However, i have finished the course of treatment and still have considerable discomfort. I sure hope the injury is not going to be permanent. I am using ice and ibuprofen, but i am awaking in the middle of the night with an intense pain/spasm at my instep.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037096 |
| MDR Report Key | 3926562 |
| Date Received | 2014-07-07 |
| Date of Report | 2014-07-04 |
| Date of Event | 2014-05-13 |
| Date Added to Maude | 2014-07-11 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| 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 | NEUROGENX 4000PRO |
| Generic Name | NEUROGENX 4000PRO |
| Product Code | GZI |
| Date Received | 2014-07-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2014-07-07 |