MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-18 for FASCIABLASTER manufactured by Ashley Black/adb Interests.
[86763811]
I began using the fasciablaster tools daily at the end of (b)(6), as directed. I used the original fasciablaster, the mini 2 and the face blaster. By (b)(6) i developed debilitating fatigue and nerve pain all over my body. I could not be out of bed for more than a few hours per day. I developed extreme emotionality that i never had before - the most intense depression, rage and anxiety alternating rapidly. I cried uncontrollably. Sounds and sudden movement caused extreme panic and feelings of distress. I felt as though my entire nervous system was on hypervigilance and i was unable to participate in my typical family or work commitments. The sense of malaise i felt was akin to a serious flu. I had hot flashes throughout the day and night and could not sleep through any night because of my extreme discomfort.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072205 |
| MDR Report Key | 6875997 |
| Date Received | 2017-09-18 |
| Date of Report | 2017-09-17 |
| Date of Event | 2017-07-15 |
| Date Added to Maude | 2017-09-19 |
| 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 | COMPONENTS, EXERCISE |
| Product Code | IOD |
| Date Received | 2017-09-18 |
| Model Number | FASCIABLASTER |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASHLEY BLACK/ADB INTERESTS |
| Brand Name | MINI2 |
| Generic Name | COMPONENTS, EXERCISE |
| Product Code | IOD |
| Date Received | 2017-09-18 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ASHLEY BLACK/ADB INTERESTS |
| Brand Name | FACEBLASTER |
| Generic Name | COMPONENTS, EXERCISE |
| Product Code | IOD |
| Date Received | 2017-09-18 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | ASHLEY BLACK/ADB INTERESTS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-09-18 |