MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-13 for FASCIABLASTER manufactured by Adb Interests Llc.
[86241372]
I followed the protocol that ashley black advised. Go to a pain level 7 for 4-5 minutes on each area. This was very painful, but ashley black called herself a scientist, said they did studies and that this was safe i thought she was a medical professional the way she proclaimed herself. I was so sore the next day, i could hardly walk. I had extreme bruising. I felt so awful and fatigued i missed 4 days work. When i reached out on the group and sent photos of my bruises, ashley black praised me and said i was doing it right.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072130 |
| MDR Report Key | 6864600 |
| Date Received | 2017-09-13 |
| Date of Report | 2017-09-13 |
| Date of Event | 2017-01-20 |
| Date Added to Maude | 2017-09-14 |
| 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 | 2017-09-13 |
| 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 | 1. Other | 2017-09-13 |