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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASHLEY BLACK / ADB INTEREST, LLC. FASCIABLASTER; COMPONENTS, EXERCISE
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ASHLEY BLACK / ADB INTEREST, LLC. FASCIABLASTER; COMPONENTS, EXERCISE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Ambulation Difficulties (2544)
Event Date 05/31/2017
Event Type  Injury  
Event Description
Purchased a fasciablaster by ashley black in (b)(6) 2017, started using it, as per directions given on her website/(b)(6) group, in hopes to help with cellulite.By (b)(6) 2017 i started noticing little veins popping on my leg, which she claims is normal and will go away in time, then developed pain in my right leg, and couldn't walk on it, had to wear brace for several months.And use the 'rice' method to ease pain.I had feared a blood clot by its symptoms and sought a professional.I stopped using the device.No clot found.Fast forward a year and i decide to try it one more time in hopes my leg injury was due to something else.Within a week the same pain and symptoms came back after being gone for 8 months.My veins that have popped up in the first few months of using it are still very visible and i have reddening of the skin around my ankles.I don't plan on using this ever again.I was bullied in the "groups" (b)(6) page when i reached out about my issues and told i just wasn't using it right.I had followed her protocol of the device, which i understand has seemed to have changed since the beginning, but i was using her most updated "method.".
 
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Brand Name
FASCIABLASTER
Type of Device
COMPONENTS, EXERCISE
Manufacturer (Section D)
ASHLEY BLACK / ADB INTEREST, LLC.
MDR Report Key8046071
MDR Text Key126596617
Report NumberMW5081109
Device Sequence Number1
Product Code IOD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age44 YR
Patient Weight91
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