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
• MDR Text Key: 77860712
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 66