FASCIABLASTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-13 for FASCIABLASTER manufactured by Ashley Black/adb Interests Llc.

Event Text Entries

[86279335] I started using the fasciablaster in (b)(6) 2016 per the instructions that were shown in numerous videos. After the very first session i became very sick with flu like symptoms and full body pain and could not get up for 2 days. I checked in with the company and was told it was detox and that i needed to keep going harder, faster, longer and to heat up my body more. By (b)(6) i started noticing that i was bigger all over and i asked questions and was told i wasn't using the product hard enough, that i needed to bruise my body and heat up more. I could not maintain everything that i was told by the ashley black company to do to abuse my body. I am a highly educated person and i researched this product for several months before i ever even purchased. There were never any negative side effects listed anywhere. I later learned that they delete any posts or side effects. My hormones became quickly out of balance. My cycle stopped in (b)(6) 2016 after the very first time i used the product and did not return for 5 months. My breasts enlarged and became very painful and tender. I kept slowing down and not using the fasciablaster as much because i could not deal with the side effects. All questions that i received from the company repeatedly told me that no one never had any side effects like mine and weight gain was impossible with this product even though i knew i was dealing with inflammation. I finally quit altogether the first week of (b)(6) 2016 and tried to restore my body. I now have cellulite from head to toe that did not exist previously. I went to 4 different doctors to see what was going on with my rapid weight gain and no one could figure it out. I didn't think to mention the product i had used. I had bloodwork done. I ended up with severe anxiety in (b)(6) 2016 due to the symptoms i was experiencing and also discovered that i had a (b)(6) infection in my bladder. I have never had a uti or anything like this previously and my doctor was baffled. I sterilized the fasciablaster before and after every single use so i have no idea how this occurred. It has been almost a year singe i stopped and i still can not get all the weight off that i gained despite going through 2 rounds of medically supervised weight loss programs. I should have known better to ever use this product and it has cost me dearly with my mental and physical health. My body is not the same and i am a very active material artist that is very aware of their body and i keep in shape and eat a very healthy diet. I wanted to enhance my muscle activation with the fasciablaster and was told that the product would help with that but when i would contact the company for help or to report issues i was blamed for eating poorly (which never happens as i have a lot of food allergies and do not eat any processed foods at all. Eat an antiinflammatory diet so that i can stay in shape for my art. ) i was blamed for not using the product long or hard enough to cause a lot of bruising or using it on the pain scale 7 which was the recommended level. I simply could not do 45 minutes of this on each leg. It was exhausting. I was blamed for not heating enough and the list goes on. I've seen bad reactions shared by others deleted from the group for coaching. It is the craziest thing i've ever seen. I did return the product and was refunded only partially. It was discovered that the product contains bpa and i had directly asked if there was bpa in it before i purchased it and i was told there was not. I feel this is a very harmful product and should be taken off the market. Users are encouraged to basically abuse their bodies and then are blamed for adverse reactions to subjecting themselves to hours of this product use. Bad reactions are hidden so no one can make an educated decision.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5072129
MDR Report Key6864589
Date Received2017-09-13
Date of Report2017-09-13
Date of Event2016-06-01
Date Added to Maude2017-09-14
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 Report3

Device Details

Brand NameFASCIABLASTER
Generic NameCOMPONENTS EXERCISE
Product CodeIOD
Date Received2017-09-13
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerASHLEY BLACK/ADB INTERESTS LLC


Patients

Patient NumberTreatmentOutcomeDate
10 2017-09-13

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