MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-18 for FASCIABLASTER manufactured by Ashley Black.
[111728935]
Was instructed to blast for pain relief and to help appearance of cellulite. After months of blasting, i started having two periods a month. They were more painful. Went to er with extreme pain on time and had a 5cm ovarian cyst, followed up with on who put me on birth control to help stop the cyst from forming. Anxiety increased while using product. Was told it was just detox and was normal. We blasting for sciatica as instructed by ashley blacks videos. Was left with worse sciatic pain and needed surgery to relieve pain. The product had protocols that changed all the time. Shady business practices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077915 |
| MDR Report Key | 7613348 |
| Date Received | 2018-06-18 |
| Date of Report | 2018-06-15 |
| Date Added to Maude | 2018-06-19 |
| 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 | 0 |
| Brand Name | FASCIABLASTER |
| Generic Name | FASCIABLASTER |
| Product Code | IOD |
| Date Received | 2018-06-18 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASHLEY BLACK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-18 |