MAUDE Adverse Event Report: ASHLEY BLACK GURU / ADB INTERESTS, LLC FASCIABLASTER ORIGINAL; MASSAGER THERAPEUTIC, MANUAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bruise/Contusion (1754); Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 03/23/2017

Event Type  Injury  

Event Description

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.

• Brand Name: FASCIABLASTER ORIGINAL
• Type of Device: MASSAGER THERAPEUTIC, MANUAL
• Manufacturer (Section D): ASHLEY BLACK GURU / ADB INTERESTS, LLC
• MDR Report Key: 8424766
• MDR Text Key: 139092197
• Report Number: MW5084925
• Device Sequence Number: 1
• Product Code: LYG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/12/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 48 YR
• Patient Weight: 51