FASCIA BLASTER

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 FASCIA BLASTER manufactured by Ashley Black Guru.

Event Text Entries

[82059735] I purchased a product called the fascia blaster, advertised by ashley black. There are a number of different groups on (b)(6) that 1,000's of women belong to. All forums are closed until you are allowed in. There are a few forums that are only for positive reviews and there are a couple of forums for the women blocked from the "positive results" forum that post the negative side effects they want women to know about before they use or continue to use the fascia blaster. When i purchased the fascia blaster, i was only aware of the "positive" forums. I did not know about the "stay calm and informed" forum. " if i did, i never would have used this device. If these women were allowed by ashley black to post their personal reviews on her main (b)(6) page, for everyone to eat and decide for themselves if using this product was a risk on their own. Before the fascia blaster arrived, i had a week to watch all the ashley black tutorials, dozens of them, all of the video on (b)(6) showing women how to use the fb, as well as read her book. "the cellulite myth. " by the time the fb arrived, i had understood how to use it and all the many benefits it would bring me. I used the product for 3 actual sessions in one week, skipping a day in between. The first two times, i had no adverse reactions. Meaning no horrible bruising, no aches and pains, no headaches and no lethargy. Just prior to the third time i used it, i watched a video of ashley telling her followers it's worked the best when your body is thoroughly heated. She sits in a sauna and fascia blast, other women fascia blast in a hot steamy shower. I decided to perform this session in the hot shower for lack of a sauna. It was more difficult that the other two sessions because the water, stream and "blasting oil" made the device slippery. I was in the shower for approx 40 min stopping intermittently to take a breath of cool air from behind the shower curtain. All three times i blasted no more than at a pain scale of 2, even though ashley suggested in several tutorials to "blast up to a pain level of 7". No thank you - you should see the bruising of the women who listened to this advice. When i was finished, i sat in a tub filled with cold water to "flush" as the calls it. Within 10 minutes of getting out of the shower, i was super tired, dizzy, nauseated and had a terrible headache. This lasted more than two weeks, everyday all day. Her "team" told me it was detoxification. My doctors told me to detox last that long. Also, the next morning after walking from feeling so sick, my legs, feet, hops, and lower back felt broken. I had hot spots and throbbing veins deep within my legs immediately when i opened my eyes. Sharp pains in my feet and toes. This has gone on for over one month and is not getting any better. Over the course of two weeks, i developed many patched of spider veins and blue green veins that were not there, everywhere i had the "hot spots. " i knew my circulatory system had been compromised and my tendons and joints in my body felt like i had arthritis. I emailed ashley and her team many times asking them what was happening to me. One girl kept in touch, only when i followed up with her. She kept telling me they haven't heard of this from anyone before insinuating it was user error and/or i had pre existing conditions. None of this is true, i emailed every person she told me too, and all i got was "my emails must have been lost? " of course. I have been going to acupuncture to try and help my body heal itself. I have talked with a rolling expert about the device and what happened. Her response was the tool is not meant to be in the hands of ordinary people who are not trained to manipulate the fascia. Today i went to a vascular doctor who performed ultra sound on my legs. I have reflux in both legs that run up from my ankle to the back of my thigh on the left and the ankle to the knee on the right. My dr told me never touch the facia blaster again. I have visited a couple acupuncture specialists. I have had a phone conversations and text messaging with a rolfing therapist. I have emailed to dr discussing the pain and stress as to what happened to me i have ultrasound results showing multiple veins that were stressed due to the use of the fascia blaster. I have many corresponding messages with the women i eventually found on the "stay calm" forum discussing my injuries and how common they really are even though ashley's "special cases" team told me i was basically one of a kind. All lies, i also have all the messages i sent to ashley and her team begging someone to tell me it was going to get better and other women experienced it as well. None of this happened. I still have to get in to see a dr about the arthritic pain or "my feet are broken" pain i have daily. There are two new publications that came out in the last week, one by buzz feed and the other i believe from "(b)(6)? " telling the stories of the women hurt by this product. Women have been trying to warn other women about the unk possible side effects that can happen, even if they are healthy individuals like myself. The company blocked all negative comments so it doesn't hurt the sales. Please look into this. There is a law suit against her now in (b)(6). I believe because this poor woman was so hurt by this device, worse than myself. This device has cost me my freedom to not think about anything but the pain i feel on a daily basis. If only i have known about the possible side effects, i'm the person who would have read one negative effect and decided "not for me". This woman. Frequency: 3 times a week, route: applied to a surface, usually the skin. Dates of use: (b)(6) 2017. Diagnosis or reason for use: release tight fascia, rid of cellulite, firm skin.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5071384
MDR Report Key6770529
Date Received2017-08-03
Date of Report2017-08-03
Date of Event2017-07-01
Date Added to Maude2017-08-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameFASCIA BLASTER
Generic NameFASCIA BLASTER
Product CodeIOD
Date Received2017-08-03
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerASHLEY BLACK GURU


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2017-08-03

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