MAUDE Adverse Event Report: ASHLEY BLACK SYSTEMS/ADB INTERESTS LLC FASCIABLASTER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bruise/Contusion (1754); Inflammation (1932); Arthralgia (2355); Reaction (2414); Weight Changes (2607)

Event Date 04/04/2017

Event Type  Injury  

Event Description

I used a tool called the fasciablaster. It causes severe bruising and inflammation. It has caused damage to my connective tissue and caused me to gain weight due to the inflammation in my body. (b)(4) systems claims this product is 100 percent safe and that it is approved by the fda as a class 1 medical device. I am one of many women who have experienced horrible reactions. I went to the doctor and she told me to stop using it and that it was most likely causing inflammation which contributed to my weight gain and achy joints.

• Brand Name: FASCIABLASTER
• Type of Device: FASCIABLASTER
• Manufacturer (Section D): ASHLEY BLACK SYSTEMS/ADB INTERESTS LLC
• MDR Report Key: 6585233
• MDR Text Key: 75869028
• Report Number: MW5069945
• Device Sequence Number: 1
• Product Code: IOD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• 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

Patient Treatment Data

Date Received: 05/20/2017 Patient Sequence Number: 1