MAUDE MDR 8046071

MDR report key
8046071
Report number
MW5081109
Event key
0
Event type
3
Date of event
2017-05-31
Date received
2018-11-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FASCIABLASTERCOMPONENTS, EXERCISEASHLEY BLACK / ADB INTEREST, LLC.IODI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-0601. S

Event Narratives#

D

Patient 1

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."