FASCIABLASTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-03 for FASCIABLASTER manufactured by Ashley Black / Adb Interests Llc.

Event Text Entries

[82017737] Purchased the fasciablaster in (b)(6) 2016 after joining the private fasciablaster (b)(6) group in (b)(6) 2016. I did months research finding nothing negative about this tool. I saw various great before and after photos that were posted. During this time, i could not find any negative comments. Right after i started in (b)(6), i began to bruise severely and experienced extreme detox symptoms. For the next 6 months, i was so sick with some of the following problems, nausea, vomiting, dizziness, vertigo, anxiety, depression so severe that i contemplated suicide in (b)(6). I was sick in bed so lethargic that i could barely walk to the restroom. I visited many doctors who could not find a problem other than i was continually sick. I was prescribed various medications on every visit to combat all these various illnesses. I have fusions in my back l3, l4, l5, s1. I have peripheral neuropathy in my legs and feet which has caused my feet to ache more. My legs are not only mushy from rubbing this on my legs everyday for months but i have crepe skin that have my legs looking like they belong to a 90 y/o woman. I failed to mention to my doctors that i had incorporated the fasciablaster into my life until recently, of which they have never heard of it. It was not until i found an alternative group did, i even contemplating this tool that could be a problem. I reported all these symptoms to ashley black on her guru site but was blocked from her (b)(6) page group and was unable to communicate with her. Originally i had left a glowing review but changed it after experiencing all the negative side effects. This product should be taken out of the consumer hands as it is dangerous. I contacted ashley black guru page to modify them of my injuries. I was blocked from communicating with them even though they sent me an email later that was computer generated that had nothing to do with my problem. Fasciablaster a tool that you take over your body to rid it of cellulite. Document number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5071365
• MDR Report Key: 6766860
• Date Received: 2017-08-03
• Date of Report: 2017-07-23
• Date of Event: 2016-09-24
• 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

Device Details

• Brand Name: FASCIABLASTER
• Generic Name: COMPONENTS, EXERCISE
• Product Code: IOD
• Date Received: 2017-08-03
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ASHLEY BLACK / ADB INTERESTS LLC

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-08-03