MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-10 for FASCIA BLASTER manufactured by Ashley Black / Adb Interests, Llc.
[89221062]
Using the (b)(6) fascia blaster for a year and ended up with very damaged skin (sagging, loose, saggy knees, lines from claws, broken capillaries, spider vein, bruise staining, weird little lumps, cellulite worsened) hormones high, adrenal fatigue. Had to get cortisone and hormone support. , iron low for first time in life, exhausted, depressed, muscles turned to mush, weird chunks above my knees, my once defined arms are now mush. Private consult with dr. (b)(6) assistant but can't prove anything is from blaster which is why this woman is getting away with this. I can't believe it's on the market still. So many are being hurt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072657 |
| MDR Report Key | 6935674 |
| Date Received | 2017-10-10 |
| Date of Report | 2017-10-05 |
| Date of Event | 2016-12-01 |
| Date Added to Maude | 2017-10-10 |
| 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 | 2017-10-10 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASHLEY BLACK / ADB INTERESTS, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2017-10-10 |