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

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.

• Brand Name: FASCIABLASTER
• Type of Device: FASCIABLASTER
• Manufacturer (Section D): ASHLEY BLACK/ADB INTEREST, LLC; TX
• MDR Report Key: 6647156
• Report Number: MW5070461
• 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: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• 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 Weight: 66
• Patient Outcome(s): Required Intervention