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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Bruise/Contusion (1754); Emotional Changes (1831); Pain (1994); Weakness (2145); Anxiety (2328); Complaint, Ill-Defined (2331); Depression (2361); Lethargy (2560)

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).

• Brand Name: FASCIABLASTER
• Type of Device: FASCIABLASTER
• Manufacturer (Section D): ASHLEY BLACK LLC/ ADB INTEREST LLC
• MDR Report Key: 6585274
• MDR Text Key: 75882860
• Report Number: MW5069950
• Device Sequence Number: 1
• Product Code: IOD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 55