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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASHLEY BLACK / ADB INTERESTS, LLC FASCIA BLASTER; COMPONENTS, EXERCISE

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ASHLEY BLACK / ADB INTERESTS, LLC FASCIA BLASTER; COMPONENTS, EXERCISE Back to Search Results
Medical Device Problem Code Insufficient Information (3190)
Health Effect - Clinical Codes Bruise/Contusion (1754); Swelling (2091); Weight Changes (2607)
Date of Event 03/27/2017
Type of Reportable Event Serious Injury
Event or Problem Description
I worked really hard to lose 180 pounds through diet and exercise.My weight loss success has been featured on tv, in magazines and on various websites.I still emotionally struggled with the appearance of my tummy because of the loose skin.I asked ab via messaging this page if it would help and was told that this can help tighten the skin and given a whole bunch of links to read more and watch helpful videos.I bought the full size blaster and the book (which i read in full) and started following various blasting protocols - blast your whole body not just your trouble spots, heat up, used oil, flush, start slow and build up, etc.I followed along with various motivator videos step by step showing full body blasting, bruised quite a lot and kept going.I wasn't seeing results so i bought the blaster oils and the nugget and kept going.I saw some tightening of my loose skin when my abdomen would swell after a blaster, but never lasting.I started blasting (b)(6) 2017.Since then, less than two months later, i've gained 10 pounds.As i mentioned, i'm pretty well versed in weight loss.In fact, the 180 pounds was lost when i started a low carb diet and fitness program (b)(6) 2014.It took two years to get to my goal weight and i maintained the weight loss for a full year.I never gained more than five pounds that didn't come right back off at any point over the last three years, until i started blasting.Worse, after losing all of that weight i was almost completely symptom free from my pcos troubles that had haunted me most of my adult life - but i started having hormonal acne flare ups again once i started blasting.I absolutely believe that blasting releases toxins as stated in the earnings, to include, and which i was not really aware of - a huge surge in hormones such as estrogen.As the daughter and granddaughter of estrogen-driven breast cancer survivors, and someone that had worked so hard to keep my hormone levels stabilized and lose the equivalent of an entire person in body weight - i never would have started this "regimen" had i known these things.I've learned my lesson, i quit blasting completely a week ago and now i'm working on getting those terrible ten pounds back off my body and just accepting my loose skin and cellulite.My weight loss is about all of the health conditions i once had and improvements i saw and the ability to get away from all of my prescription medications which far outweighs having a flat, tight tummy.I knew this, but i was swayed into buying and trying anyway.Let me be very clear - i have not eaten sugar in over three years, i have not changed my diet at all in the last year plus of maintaining my new healthy weight and i have not changed my fitness routine except that if anything, i added some "exercise" in the form of spending a few hours a week scrubbing my skin with the fascia blaster which can be a workout in itself.I can't prove that blasting caused my weight gain, or the actually worse looking skin on my upper thighs and batwings, but it's an awfully strong coincidence that these things happened only after i bought my fascia blaster, without ever straying from my healthy diet that let me lose so much weight and keep it off for an entire year and without ever missing a workout.I drink a gallon of water a day, i workout, i eat healthy - i've been doing everything "right" and am so angry at myself for even trying this to begin with.Ten pounds doesn't sound like a lot but after a lifetime of being obese to becoming successful and a healthy weight, and while i'm literally having an agent pitch my story to publishers to secure a book deal, i can't emotionally or financially afford to have any kind of weight gain - if it wasn't my own carelessness, sure - but this fascia blaster was advertised as a tool that could cause weight loss, reduce stomach fat and i was personally told that it would tighten my loose skin.Two days ago warning for weight gain was added to side effects.
 
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Brand Name
FASCIA BLASTER
Common Device Name
COMPONENTS, EXERCISE
Manufacturer (Section D)
ASHLEY BLACK / ADB INTERESTS, LLC
MDR Report Key6593564
Report NumberMW5070026
Device Sequence Number690191
Product Code IOD
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 05/24/2017
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
Operator of Device No Information
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/24/2017
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age37 YR
Patient Weight76
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