MAUDE MDR 6876009

MDR report key
6876009
Report number
MW5072206
Event key
0
Event type
3
Date of event
2017-04-15
Date received
2017-09-18
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 INTERESTSIOD2.0 092116I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-1801. O

Event Narratives#

D

Patient 1

I STARTED BLASTING IN (B)(6) 2016, THEN IN (B)(6) OF THIS YEAR MY ENTIRE BODY WAS COVERED IN A HORRIBLE CASE OF HIVES! I WAS LITERALLY COVERED FROM MY HEAD TO MY WRISTS AND ANKLES AND IT LASTED FOR OVER A MONTH AND ITCHED/BURNED CONSTANTLY! I WAS MISERABLE! I FOUND OUT THAT IT WAS DUE TO INFLAMMATION FROM MY BODY REACTING TO THE DAMAGE THE BLASTER WAS DOING TO MY BODY. I WAS SEEN TWICE BY MY PCP. THE FIRST APPOINTMENT, HE GAVE ME A STEROID SHOT TO TRY TO GET RID OF THE HIVES BUT AFTER A WEEK, THERE WAS NO IMPROVEMENT. THE SECOND APPOINTMENT, I WAS GIVEN A STEROID PACK THAT RELIEVED MY SYMPTOMS ON DAY THREE OF TAKING THEM BUT THE DAY AFTER I FINISHED THE 5 DAY PACK, THE HIVES CAME BACK EVEN WORSE. AFTER MORE THAN A MONTH, I WAS FINALLY ABLE TO GET SOME RELIEF WITH A PRODUCT FROM THE NATURAL FOOD MARKET. I STOPPED BLASTING WHEN THE HIVES APPEARED, AND DURING THE MONTH I WASN'T BLASTING, I NOTICED THAT SEVERAL AREAS OF MY BODY BUT MOST NOTICEABLY, MY THIGHS AND KNEES ARE LITERALLY COVERED IN CELLULITE AND NOW HAVE ODD INDENTED AREAS. BUT BEFORE I STARTED BLASTING, THOSE WERE ONE OF MY FAVORITE AREAS OF MY BODY. I'D WEAR SHORTS EVERY CHANCE I COULD, I AVOID THEM NOW. THE ONLY REASON I EVER BLASTED THEM WAS BECAUSE ACCORDING TO (B)(4), THEY WERE "BEYOND BOUND". I ALSO GAINED 15 POUNDS WHILE I WAS BLASTING.