FASCIABLASTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-02 for FASCIABLASTER manufactured by Adb Interests, Llc.

Event Text Entries

[82011524] I began using the fascia blaster by (b)(6) 2016. Since i began blasting, i began getting real bad depression, anxiety, real bad flu symptoms and insomnia. I have seen my doctor several times and have had several tests done and they come out normal. I went back for a follow up appointment and told him that i was using the fb blaster. I explained a little on what the fb does and the detox symptoms it could have. He told me to stop using that thing. I told him i stopped using it but i'm still feeling really sick. He said that whatever i was using and was bruising my body, the way i explained to him sounds very dangerous to my health. He told me not to use anything like that ever again on my body. My life has turned to the worst from my cellulite being worse than ever to having to call out of work a lot from the horrible detox. I became real sick with a "virus" that lasted over a month. I have never had a "virus" for so long in my life and i am (b)(6) years old. I regret so much spending so much money on all of those stupid gadgets and a book that i've never even read. I also paid lots of money to a massage therapist to blast me and it hurt so bad. I was bruised all over and in pain, for what! For nothing because now i look worse and feel worse than ever! My eye sight also became affected. My eye glass prescription had to be changed 3 times since (b)(6). My clinician changed my depression and anxiety and medications several as the mess were not working. When i told her what i was doing and showed her pictures, she told me to stop using that thing immediately. I would also like to let you know that my depression was so bad that i even contemplated suicide as i didn't want to feel the way i did. I thank god that those feelings went away but i still feel depressed, tired, weak and dizzy all the time. I also have a lot of inflammation all over my body that makes it hard for me to do a lot of the things that i usually do. Ms. (b)(6) threatens to sue anyone who posts anything negative about her product. She's suing several of the ladies in the (b)(6) groups. Her protocols have changed so many times and then blames us the consumers if we get sick, hurt or didn't get good results.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5071359
MDR Report Key6766752
Date Received2017-08-02
Date of Report2017-08-02
Date of Event2016-12-05
Date Added to Maude2017-08-04
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 NameFASCIABLASTER
Product CodeIOD
Date Received2017-08-02
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerADB INTERESTS, LLC


Patients

Patient NumberTreatmentOutcomeDate
10 2017-08-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.