MAUDE Adverse Event Report: ASHLEY BLACK / ADB INTERESTS, LLC. FASCIABLASTER MINI2; MASSAGER, THERAPEUTIC, MANUAL

Device Problem Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Headache (1880); Skin Irritation (2076)

Event Date 01/12/2017

Event Type  No Answer Provided  

Event Description

On may 13, 2019: to whom it may concern: on (b)(6) 2017 i bought the mini 2 fascia blaster from (b)(6), an ashley black company, (b)(6).This purchase was made from advertising i saw on the social media platform (b)(6) via this link: (b)(6).I was then able to make my purchase using my debit card and my order number was (b)(6) with a tracking number of (b)(6).Unfortunately, the product was not performing as advertised and potentially presents a health risk to purchasers which was not disclosed to the customers other than through the business owner's closed (b)(6) group where support and customer service is supplied and many verified customers have been blocked from having access after notifying the business owner of issues of use of the product.These warnings were not in place prior to me purchasing, and are not made readily apparent until you seek them out in the terms and conditions of the website.I received no e-mail from the company about this change although i am on their e-mail list, since i continue to receive e-mails about new products and promotions and in fact the new terms and conditions were pointed out to me by other users having similar issues with the product.I believe that false claims, as well as medical advice being offered and many health conditions being "cured" induced me to purchase.Additionally, i have concerns since it has been shown that pictures that are taken from cosmetic surgery sites have been discovered being used as before and afters of results of the product and pointed out to the business owner selling the product, yet she continues to use them to advertise.The business owner cites a study that was done as proof of what the product can and cannot do, yet refuses to release the results of said study which by all accounts, in fact is not a true "study" although presented as such.My reason for purchasing the mini2 fascia blaster was mainly ashley black's claims that it helped with migraine headaches, which i greatly suffer from.Second reason was to help define muscle tone.This purchase was made on (b)(6) 2017.My results - no relief of my migraines, made them worse, made them so bad i had to seek medical attention.Once i stopped using the fascia blaster my skin is awful, looks creepy like it aged 30 years.I had communication with (b)(6) directly and also with her moderators in her groups about how my migraines got worse; every time i was told, "oh you're detoxing," or "keep up with it." as for when i tried to tell them how it ruined my skin (b)(6) herself asked why would you stop? i attached a screenshot of the conversation.When i tried to warn new users what happens to your skin if you stop you just get banned from the group.Totally unfair, people need to know what the outcome will be should they decide to stop.My skin looks like i am 80 y/o now and i'm only (b)(6).It's scary what this can do to people.People need to know the full outcome of using something on their body before they use it.Had i known i had to do this the rest of my life i never would have started it.(b)(4).

• Brand Name: FASCIABLASTER MINI2
• Type of Device: MASSAGER, THERAPEUTIC, MANUAL
• Manufacturer (Section D): ASHLEY BLACK / ADB INTERESTS, LLC.
• MDR Report Key: 8758010
• MDR Text Key: 150155200
• Report Number: MW5087788
• 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: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR