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U.S. Department of Health and Human Services

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

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ASHLEY BLACK/ADB INTEREST, LLC FASCIABLASTER Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Bruise/Contusion (1754); Fatigue (1849); Inflammation (1932); Menstrual Irregularities (1959); Pain (1994); Depression (2361); Abdominal Cramps (2543); Weight Changes (2607); Heavier Menses (2666)
Event Type  Injury  
Event Description
This product is called the fascia blaster. Customers are instructed to use it as a deep massage tool to break up fascia adhesions, and it is marketed to help with pain relief and also cure cellulite. I was using this product as instructed, and i became bruised and inflamed. I was using this product as instructed, and i became bruised and inflamed. I was a member of the product owner's facebook group, (b)(6), where she provided detailed instructions (written and video) for use (instructions are not provided with the packaging). Within the facebook group feed, i noticed many other people had experienced the same reaction and (b)(6) advised them it was normal and to continue using her product. I used the product on and off for about 10 months, and every time, i would suffer inflammation. (b)(6) said we were in the "worse before better" phase. Because of that, i continued. Other adverse symptoms i experienced using the fascia blaster include: weight gain, irregular periods, heavy periods, spotting between periods, stomach cramping for days after product use, depression, and exhaustion. In addition, i was told to use the product at a pain level up to 7, and in doing so on my lower back, i believe i may have damaged or disconnected the muscles from my lower back. I now suffer lower back problems and have had my lower back lock up two times on me in the past month. I'm now seeing an orthopedic surgeon, a chiropractor, participating in physical therapy 2x per week, and cryotherapy (daily for inflammation). (b)(6), fasciablaster used (b)(6) 2016 to (b)(6) 2017.
 
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Brand NameFASCIABLASTER
Type of DeviceFASCIABLASTER
Manufacturer (Section D)
ASHLEY BLACK/ADB INTEREST, LLC
TX
MDR Report Key6647156
MDR Text Key77860712
Report NumberMW5070461
Device Sequence Number1
Product Code IOD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
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

Patient Treatment Data
Date Received: 06/14/2017 Patient Sequence Number: 1
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