FASCIABLASTER MINI 2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-22 for FASCIABLASTER MINI 2 manufactured by Ashley Black.

Event Text Entries

[87289045] I used the fasciablaster mini 2 for the first time on my legs, in the shower, on (b)(6) 2017 following a workout. I had previously used the device on my abdomen only during the month of (b)(6). My left inner calf muscle became sore. The following morning while walking from the parking lot to work, i felt the muscle pull very painfully. I continued to walk thinking the pain would go away, but it didn't and i could only limp. I complained about it to my boss who pointed out my left leg was now grotesquely swollen. Bruising appeared. The pain/bruising went away after approx two weeks, but the swelling was still present despite sleeping with my leg elevated. I scheduled an appointment with my pcp who could not see me until (b)(6) 2017. My doctor ordered a stat ultrasound after observing the differences in my calves and palpitating the affected area. The ultrasound determined there was no blood clot. Doctor was unable to determine what happened but instructed me to return in 6 weeks if i was still swollen for xrays and scans. I showed him the fasciablaster mini 2 and was told he couldn't say what if any affect it had on my leg but to not use it again. As of (b)(6) 2017, my leg is still swollen and i have ceased menstruation, but am not pregnant. On (b)(6) 2017 - physical exam with gynecologist to investigate absence of menstruation. No physical ailment apparent, but no blood work was taken. I will return if my next cycle is also skipped for an abdominal ultrasound/bloodwork. I am (b)(6) and have never missed a period since age (b)(6) except for when i had conceived. I have attempted to reach out to (b)(6) via her facebook group, but my comments and questions were blocked from being posted by either (b)(6) herself or her admins. I have since found an alternative group with numerous women complaining of similar treatment and similar injuries and hormonal issues. (b)(6) has now changed her terms of service and is releasing info that is contradictory to the info that was presented previously. I would not have purchased much less used this device had i known any of this. I ordered it because she said it was an fda approved medical device. I have since learned it's in the same class as dental floss and was never evaluated for use or long term effects.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5072286
MDR Report Key6885808
Date Received2017-09-22
Date of Report2017-07-14
Date of Event2017-05-15
Date Added to Maude2017-09-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 MINI 2
Product CodeIOD
Date Received2017-09-22
Model NumberMINI 2
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerASHLEY BLACK


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-09-22

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