MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-11 for FASCIA BLASTER manufactured by Ashley Black / Fascia Blaster.
[85778296]
I used the fascia blaster in a hot bath (as ashley black suggested) for thirty minutes. Twenty minutes later when i tried to walk, my body kept pulling to the right. This happened twice. My husband took me to the er and i was admitted to the hospital with having a stroke. I didn't put two to two together until a couple of months later when negative posts started getting deleted on the main page of the fascia blaster. I have stopped using it and have had no problems since. I am healthy, eat clean and work out four days a week. I was using it for pain management from my work outs. And i now have varicose veins on my legs that i did not have before using the fascia blaster. Date the person first started taking or using the product: (b)(6) 2016. Date the person stopped taking or using the product: (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072068 |
| MDR Report Key | 6854419 |
| Date Received | 2017-09-11 |
| Date of Report | 2017-09-07 |
| Date of Event | 2016-10-17 |
| Date Added to Maude | 2017-09-11 |
| 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 | FASCIA BLASTER |
| Generic Name | FASCIA BLASTER |
| Product Code | IOD |
| Date Received | 2017-09-11 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASHLEY BLACK / FASCIA BLASTER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2017-09-11 |