ASHLEY BLACK GURU FASCIABLASTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for ASHLEY BLACK GURU FASCIABLASTER manufactured by Adb Interest, Llc.

Event Text Entries

[143291620] I bought the fasciablaster from ashley black company in 10/2016, i followed her recommended protocols and watched her videos, against all odds i started feeling sick and gained weight, my menstrual period became crazy out of the charts, she claimed it was the "worst before better stage" but by late (b)(6) i noticed a big bump in my back, kind of like on top of my scapula, i got it checked in (b)(6) 2018 and it was lipoma, i spoke with my doctor about the blaster and he thinks it could be related to that. I of course stopped using it and tried to save enough money for surgery to remove the lipoma, i still can't afford it. Then i learned about all the legal issues ms black is having, the false claims and the convenient (for them) changes in their protocols. I just learned that i can return the blaster, since it is under the 1000 days guarantee, but they refuse to give me a full refund of the (b)(6) dollars i spend buying the fasciablaster. I just want a full refund from the company. The fasciablaster was replaced because it broke but the last one i received broke too. I am attaching the photo. Date the person first started taking or using the product: (b)(6) 2016. Date the person stopped taking or using the product: (b)(6) 2017. Did the problem stop after the person reduced the dose or stopped taking or using the product? Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086163
MDR Report Key8550704
Date Received2019-04-23
Date of Report2019-04-19
Date of Event2017-12-01
Date Added to Maude2019-04-25
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 NameASHLEY BLACK GURU FASCIABLASTER
Generic NameMASSAGER, THERAPEUTIC, MANUAL
Product CodeLYG
Date Received2019-04-23
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerADB INTEREST, LLC


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-04-23

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