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U.S. Department of Health and Human Services

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

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ASHLEY BLACK SYSTEMS/ADB INTERESTS LLC FASCIABLASTER Back to Search Results
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.

 
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Brand NameFASCIABLASTER
Type of DeviceFASCIABLASTER
Manufacturer (Section D)
ASHLEY BLACK SYSTEMS/ADB INTERESTS LLC
MDR Report Key6585233
Report NumberMW5069945
Device Sequence Number1
Product CodeIOD
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 05/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/20/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
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
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