FASCIABLASTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-07 for FASCIABLASTER manufactured by Ashley Black/adb Interests.

Event Text Entries

[85433316] I heard about ashley black's fasciablaster in (b)(6) 2016 on (b)(6). Her (b)(6) page was filled with inspiring stories and photos showing unbelievable changes in physical appearances of cellulite, muscle definition as well as stories that it helped with pain and migraines. Ashley encouraged customers and people on her (b)(6) page to tag her and her motivators so they could address questions and concerns so the community could read and learn from each others experiences. She could also be reached via private messages on (b)(6) and by email. Some of her (b)(6) posts would point the community to (b)(6) videos for direction as well. According to (b)(6) and (b)(6), we were to heat up in the shower, sauna or by some other method, apply oil and "blast" our entire body to a 7 on the pain scale. We should bruise and if we didn't, we needed to keep going on until we did. The bruise was a sign that we were changing the fascia. There were hundreds of pictures of bruised women and they were praised by ashley and her team. But, it appeared to work. The photos were proof. After reading the page for weeks, i ordered the fasciablaster hoping to get relief from my migraines. I didn't have much cellulite, but the possibility that it could help with muscle definition was exciting. Upon receiving the blaster, i consulted the (b)(6) page again and read the pinned instructions. I also read the instructions enclosed with the fasciablaster. They weren't nearly as detailed as everything ashley herself had posted on (b)(6) and (b)(6). And, the only thing that was warned against was blasting in a circular motion or going over the carotid artery. I started "blasting" in (b)(6) 2016. The first few weeks, i noticed that my migraines had worsened but i assumed it was because i was tensing my neck while blasting. It was hard work to blast my entire body to a 7 on the pain scale. Then my menstrual cycle, that had been very light and regular, began to change. It started lasting 7 - 12 days with a couple of days off and started again. It was heavy with many clots. My breasts got very tender and i was bloated and gaining weight. My face was breaking out and i was cranky. My husband was concerned because my legs and abdomen were black and dark red with bruises. Within two months, my menstrual cycle stopped, my migraines were worse and i was 5 pounds heavier despite a change in diet and exercise. By early (b)(6) 2016, i was unable to blast because my migraines were daily and more intense than ever. Now, six months later, my menstrual cycle has resumed, my breast feel normal and i am my normal happy self. I am not bloated but have not lost any weight despite still exercising. I have staining on my leg from the heavy bruising. My face, arms, legs and abdomen look worse than they did before starting. I have jowls on my face. My arms and legs are wrinkly and above my knees the skin is very crepey and droopy. I had an area with a few spider veins and was told to blast over them because the blood flow would make them go away and the patch is now twice the size it was.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5072014
MDR Report Key6848482
Date Received2017-09-07
Date of Report2017-09-05
Date of Event2017-02-01
Date Added to Maude2017-09-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameFASCIABLASTER
Generic NameCOMPONENTS, EXERCISE
Product CodeIOD
Date Received2017-09-07
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerASHLEY BLACK/ADB INTERESTS


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2017-09-07

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