FASCIABLASTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-06 for FASCIABLASTER manufactured by Ashley Black / Adb Interest, Llc..

Event Text Entries

[126596617] Purchased a fasciablaster by ashley black in (b)(6) 2017, started using it, as per directions given on her website/(b)(6) group, in hopes to help with cellulite. By (b)(6) 2017 i started noticing little veins popping on my leg, which she claims is normal and will go away in time, then developed pain in my right leg, and couldn't walk on it, had to wear brace for several months. And use the 'rice' method to ease pain. I had feared a blood clot by its symptoms and sought a professional. I stopped using the device. No clot found. Fast forward a year and i decide to try it one more time in hopes my leg injury was due to something else. Within a week the same pain and symptoms came back after being gone for 8 months. My veins that have popped up in the first few months of using it are still very visible and i have reddening of the skin around my ankles. I don't plan on using this ever again. I was bullied in the "groups" (b)(6) page when i reached out about my issues and told i just wasn't using it right. I had followed her protocol of the device, which i understand has seemed to have changed since the beginning, but i was using her most updated "method. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5081109
MDR Report Key8046071
Date Received2018-11-06
Date of Report2018-11-03
Date of Event2017-05-31
Date Added to Maude2018-11-07
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 Received2018-11-06
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerASHLEY BLACK / ADB INTEREST, LLC.


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2018-11-06

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