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 |