MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-02 for FASCIA BLASTER MINI 2 manufactured by Ashley Black / Adb Interests Llc.
[82015765]
Ordered a fasciablaster by ashley black guru on (b)(6) 2017. I used the product per instructions, via ashley black video posted on (b)(6) instructions. I used the product 3 times on 3 separate days. On the fourth day, following use, i noticed a lot of swelling in my abdomen, hands, and neck. By the 10th day after stopping use of the product, i had gained 16 pounds. Prior to using this product, my weight had remained the same only fluctuating a pound or two for the last 23 years. The weight gain was accompanied by nausea, hormonal and menstrual changes, lethargy and headaches. As of today (b)(6) 2017, i still have hormonal disruptions, weight gain and now my skin, where i used the product is loose and saggy. It has add'l cellulite, creepy-texture and hangs from my midsection like an apron. The skin on my thighs has permanent staining, from bruises from use of the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071368 |
| MDR Report Key | 6766897 |
| Date Received | 2017-08-02 |
| Date of Report | 2017-08-02 |
| Date of Event | 2017-06-20 |
| Date Added to Maude | 2017-08-04 |
| 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 | COMPONENTS, EXERCISE |
| Product Code | IOD |
| Date Received | 2017-08-02 |
| Model Number | MINI 2 |
| 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 | 2017-08-02 |