FASCIABLASTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-04 for FASCIABLASTER manufactured by Adb Interests, Llc.

Event Text Entries

[82328743] Adb interests, llc sells a medical/fitness device called the fasciablaster, which is primarily marketed and sold through facebook. (b)(6), the inventor of the fasciablaster and owner of adb interests, llc often misrepresents the fasciablaster as an "fda" approved device, when it is actually a class 1 exempt medical device. In addition, ms. (b)(66), who has no formal medical training nor holds any professional medical licenses, states that the fasciablaster can cure a variety of diseases, including parkinson's and fibromyalgia. Ms. (b)(6) also encourages women who are pregnant to use the fasciablaster. Hundreds of women have publically addressed the injuries they have received as direct result from the fasciablaster, however, ms. (b)(6) publically dismisses their concerns. Ms. (b)(6) will "block" concerned consumers that question the fasciablaster's safety and will censor the fasciablaster facebook page to ensure negative comments are removed. Ms. (b)(6) has no regard for the health and safety of her consumers. Ms. (b)(6) product and the complaints from the numerous injured women should be investigated. Please email me if you require additional information, such as screen shots of ms. (b)(6) comments regarding the fda approval or regarding the safety and use of the fasciablaster.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5071421
MDR Report Key6773350
Date Received2017-08-04
Date of Report2017-08-04
Date Added to Maude2017-08-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationUNKNOWN
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 Received2017-08-04
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerADB INTERESTS, LLC


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2017-08-04

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