MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-21 for FASCIABLASTER manufactured by Adb Interests Llc.
[100830820]
I started using the fascia blaster around (b)(6) 2017. She said to go to a level 7 on the pain scale, but even going lightly i would get bruises and staining that would last weeks. I tried again every time the bruising would go away, but i couldn't be consistent because of it. This product claims to get rid of cellulite, but i just kept getting more of it. I started with a little bit on my butt and the back of my legs, and when it worsened, she called it the worse before better stage. I also developed loose skin on my arms, and crepe skin on my legs and side of butt as well. After using her fascia nugget tool, i ended up with a dent in my leg. Her ads on facebook were constant, and they made it sound so easy. It definitely wasn't, i was always weak and very bruised during the process. It seems to just worsen, even though it's been like 9 months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075419 |
| MDR Report Key | 7288928 |
| Date Received | 2018-02-21 |
| Date of Report | 2018-02-18 |
| Date of Event | 2017-05-01 |
| Date Added to Maude | 2018-02-22 |
| 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 | COMPONENT, EXERCISE |
| Product Code | IOD |
| Date Received | 2018-02-21 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2018-02-21 |