MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-11 for FASCIABLASTER manufactured by Ashley Black / Adb Interests, Llc..
[113863311]
Using the fasciablaster by ashley black, i gained 25 lbs in 6 months and my cellulite is worse than ever. My hip muscle tore away from the fascia which holds muscle to bone. I had 8 wks of physical therapy before my hip stopped "rolling," bruising, swelling on my legs and arms after use of the fasciablaster. I am still doing therapy and going to chiropractor 3 days a week.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078326 |
| MDR Report Key | 7681183 |
| Date Received | 2018-07-11 |
| Date of Report | 2018-07-10 |
| Date of Event | 2017-06-29 |
| Date Added to Maude | 2018-07-12 |
| 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 | FASCIABLASTER |
| Generic Name | COMPONENTS, EXERCISE |
| Product Code | IOD |
| Date Received | 2018-07-11 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASHLEY BLACK / ADB INTERESTS, LLC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-07-11 |