MAUDE MDR 6776672

MDR report key
6776672
Report number
MW5071442
Event key
0
Event type
3
Date of event
2017-05-09
Date received
2017-08-07
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
1FASCIABLASTEREXERCISE COMPONENTSASHLEY BLACK GURUIOD2.0121516I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-0701. O

Event Narratives#

D

Patient 1

STARTED USING FASCIABLASTER (B)(6) 2017. ON (B)(6) 2017 I NOTICED PAIN IN MY RIGHT CALF. IT THEN BECAME VERY PAINFUL AND RED AND THAT'S WHEN I NOTICED A VARICOSE VEIN. I HAVE NEVER HAD ANY PREVIOUSLY. THE VEIN AND PAINFUL SWELLING WENT DOWN AFTER 3-4 DAYS BUT MY CALF IS NOW DISFIGURED. I HAVE MY CALF MUSCLE THEN A LUMP AND ANOTHER DEEP CREASE INDENTION. I ALWAYS BLASTED LIGHTLY AND TIMED AT 2-3 MINUTES PER SECTION. DUE TO BUSY SCHEDULE I ONLY BLASTED AT MAX 2 TIMES A WEEK. I STOPPED BLASTING AND DIDN'T START BACK UNTIL APPROX. (B)(6) THE PAINFUL VARICOSE LOOKING VEIN SHOWED UP AGAIN. I THEN TOOK MORE PICTURES AND NOTICED HOW CREPE AND SAGGING THE SKIN WAS ABOVE BOTH KNEES. I WAS DOING CROSSFIT PREVIOUSLY UNTIL (B)(6) 2017. FOOLISHLY, I BLASTED ONCE AGAIN AND WAS GOING TO DO THE ISOLATION EXERCISES THAT (B)(6) RECOMMENDS TO TRY AND IMPROVE THE PROBLEM AREAS I NOW HAVE. AFTER THE LAST BLAST IN (B)(6) 2017, I DECIDED THE PRODUCT WASN'T FOR ME. AS OF TODAY (B)(6) 2017 MY CALF IS STILL DEFORMED LOOKING AND I HAVE NOT BEEN ABLE TO TIGHTEN THE CREPE LOOSE SKIN ABOVE MY KNEES.