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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASHLEY BLACK LLC/ ADB INTEREST LLC FASCIABLASTER

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ASHLEY BLACK LLC/ ADB INTEREST LLC FASCIABLASTER Back to Search Results
Event Date 11/22/2016
Event Type  Injury  
Event Description

I purchased this fascia blaster and followed all the instructions per ashley black. I have fusions on la, l4, l5, s1. I9 have peripheral neuropathy in my legs and feet. I bought this product for the cellulite claim to get rid of cellulite. This product produced major bruising as i followed instructions to go to pain level 7 but with neuropathy you can't tell as you have numbness already and this just aggravated that problem even more. The bruising i encountered was severe. I happened to have a procedure done and the doctor was alarmed and told me to quit using this tool as no bruising is good bruising but, ashley black says by using this tool that the bruises you receive are healing bruises. How can i be so stupid not to follow my doctor. While using this tool they talk of detox but, no tool, pill or protocol can or should be so debilitating that a person is to be so lethargic, sick, moody, depressed or weak for 2. 5 months be a side effect as i encountered by rubbing this tool all over my body. After many months of using this product my cellulite is by far worse than what i started. The pain i have has increased by 5 times and it already is at a pain level 6. My skin has become crepe like and now looks like a 95 year old woman instead of a healthy (b)(6) woman. I have had anxiety caused by the raise in hormones as well as anemia and been prescribed medications for these problems. At the time, i did not correlate any of these problems together. The fascia blaster tool is dangerous and hurtful to the general public. Please take this tool off the market. Thank you (b)(6).

 
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Brand NameFASCIABLASTER
Type of DeviceFASCIABLASTER
Manufacturer (Section D)
ASHLEY BLACK LLC/ ADB INTEREST LLC
MDR Report Key6585274
Report NumberMW5069950
Device Sequence Number1
Product CodeIOD
Report Source Voluntary
Reporter Occupation Patient
Report Date 05/22/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/22/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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