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 |