MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-14 for SPINECOR BRACE manufactured by Spinecor.
[31576941]
I was prescribed a spinecor brace by a chiropractor for adult scoliosis. After wearing the brace for 2 weeks during which i was instructed to build up the time from 2-3 hours per day to 12 hours per day i was unable to get to more than 4 hours per day and my pain which had only been in my right back while sleeping is now severe and occurs almost all day as well as being worse than previously at night. In addition i now have radiating pain and numbness down my right lateral thigh and into my right upper knee cap that i never had before. It has been over 3 weeks since i wore the spinecor and the pain is no better. It is severe (9/10).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057927 |
| MDR Report Key | 5235216 |
| Date Received | 2015-11-14 |
| Date of Report | 2015-11-14 |
| Date of Event | 2015-11-14 |
| Date Added to Maude | 2015-11-19 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPINECOR BRACE |
| Generic Name | SPINECOR BRACE |
| Product Code | IPY |
| Date Received | 2015-11-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPINECOR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-14 |