FASCIABLASTER PAT # D735.818

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-01 for FASCIABLASTER PAT # D735.818 manufactured by Ashley Black Guru/adb Interests.

Event Text Entries

[84643939] I began using this tool (b)(6) 2016. I have my blood levels checked every three months, due to a medication that i am required to take. This tool was marketed for pain relief. I found that when i would do a pain relief protocol treatment, my liver enzymes would go to a very alarming high level, along with being diagnosed with anemic levels as well. The first few times that i had these diagnosed, i did not put it together that this tool was causing the alarming raise in toxic blood levels. Over the course of the last year, i have been speaking with many other women who use this tool and we're suffering the same symptoms, it was at that time, i was able to put two and two together. Due to the fact that this tool caused the toxic levels in my liver, my doctor presumed that it was my medication, that i required to stay alive. He recommended i try to get off of my medication, he did not know what i was doing to my body with this tool, in order to alleviate body pain that is a side effect of my disease and the medication that i take. When used on the body mounting stories are becoming very apparent, this tool causes a severe level of a detox on the body, to be marketed as it has been, along with the protocols that we are rolled out with this device. In addition to toxic blood levels i have experienced many areas of sagging and rapidly aging skin. My arms, belly, neck and legs have suffered pre-mature aging and sagging. I spoke with the creator and developer of the tool on (b)(6). I told her about my reoccurring liver enzyme issues and my belief that the tool is the cause of the high levels. The developer ashley d. Black refused to accept my findings as to be correlated with her product. Ms. Black kept referring to a "study" that she had done. This "study" has since been brought into question as to its true results and is being unethically pushed on us consumers as a viable "clinical study".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5071918
MDR Report Key6839155
Date Received2017-09-01
Date of Report2017-08-30
Date of Event2017-05-05
Date Added to Maude2017-09-01
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 NameCOMPONENT, EXERCISE
Product CodeIOD
Date Received2017-09-01
Model NumberPAT # D735.818
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerASHLEY BLACK GURU/ADB INTERESTS


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2017-09-01

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