MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-14 for FASCIABLASTER ORIGINAL manufactured by Ashley Black Guru / Adb Interests, Llc.
[139092197]
I purchased the original fasciablaster, the mini2 and the faceblaster to help alleviate symptoms associated with a diagnosed autoimmune disorder. Mixed connective tissue disease. I used all three off and on for less than a year, following the instructions provided in the packaging as well as those provided in (b)(6) video tutorials. Not only did it not work to alleviated my pain, it made it worse and any cellulite i had worsened after extreme bruising. The skin on my upper arms, inner thighs, stomach and especially my neck area is now sagging and creepy. I have been told that the only way to restore the skin on my neck is with a lower facelift. Worse than that, it appears the usage of the fasciablaster products caused early menopause at the age of (b)(6). I have been on estrogen and progestin for two years now and because of a family history of breast cancer, i can only be on the lowest dosage possible and must have routine mammograms and ultrasounds. I have not had a menstrual cycle since using the fasciablaster. I returned the mini2 for a refund, however i could not return the fasciablaster because i could not find record of my receipt, and the company would not allow returns on the fasciablaster if even one of the oils was opened, which it was. After learning of so many women being damaged by these products, i wanted to make sure i came forward to include what i've personally experienced in the hope that the products are banned completely. You are welcome to contact me if you need further info.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084925 |
| MDR Report Key | 8424766 |
| Date Received | 2019-03-14 |
| Date of Report | 2019-03-12 |
| Date of Event | 2017-03-23 |
| Date Added to Maude | 2019-03-15 |
| 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 ORIGINAL |
| Generic Name | MASSAGER THERAPEUTIC, MANUAL |
| Product Code | LYG |
| Date Received | 2019-03-14 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASHLEY BLACK GURU / ADB INTERESTS, LLC |
| Brand Name | MINI2 |
| Generic Name | MASSAGER THERAPEUTIC, MANUAL |
| Product Code | LYG |
| Date Received | 2019-03-14 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ASHLEY BLACK GURU / ADB INTERESTS, LLC |
| Brand Name | FACEBLASTER |
| Generic Name | MASSAGER THERAPEUTIC, MANUAL |
| Product Code | LYG |
| Date Received | 2019-03-14 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | ASHLEY BLACK GURU / ADB INTERESTS, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2019-03-14 |