MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-25 for FASCIABLASTER 1.0 011017 manufactured by Adb Interests, Llc.
[87507537]
I began using the fasciablaster tool on my legs in (b)(6) 2017, and by the end of the month began experiencing pain near my hips on both sides. The intensity increased so i consulted with a rheumatologist who identified the injury as bing trochanteric bursitis. He said it's not joint issues but that the bursa gets inflamed by muscles and tendons rubbing over the bursa and causing friction on the thigh bone. I have since discontinued use of the tool but my inflammation and pain continue. It has limited my activity greatly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072421 |
| MDR Report Key | 6893931 |
| Date Received | 2017-09-25 |
| Date of Report | 2017-09-23 |
| Date of Event | 2017-05-31 |
| Date Added to Maude | 2017-09-26 |
| 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 | 0 |
| Brand Name | FASCIABLASTER |
| Generic Name | FASCIABLASTER |
| Product Code | IOD |
| Date Received | 2017-09-25 |
| Model Number | 1.0 011017 |
| Lot Number | 1.0 011017 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADB INTERESTS, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-09-25 |