MAUDE MDR 6883184

MDR report key
6883184
Report number
MW5072251
Event key
0
Event type
3
Date of event
2017-07-17
Date received
2017-09-20
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
1FASCIA BLASTERFASCIA BLASTERASHLEY BLACK/ PANALPINA / ABD INTERESTS, LLCIODI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-2001. H

Event Narratives#

D

Patient 1

BOUGHT THE FASCIA BLASTER (B)(6) 2017 AS IT WAS ADVERTISED TO HELP WITH PAIN. WAS AT THE TIME HAVING LOWER BACK PAIN FOR 10 MONTHS. STARTED USING THE 3 FASCIA BLASTERS AND ONLY USED LIGHT AND 1-3 MINUTES PER AREA. NEVER WENT TO A PAIN LEVEL OF 7 AS (B)(6) RECOMMENDED. STARTED READING ONLINE ABOUT HOW THE OWNER (B)(6) SUDDENLY CHANGED TERMS AND CONDITIONS TO INCLUDE THAT THE FASCIA BLASTER CAN CAUSE WEIGHT GAIN, INFLAMMATION, ETC AND THAT THE FASCIA BLASTER HAS BPA IN IT. ALSO STARTED READING ABOUT WOMEN CLAIMING INJURY FROM USE OF THE FASCIA BLASTER AND A VARIETY OF HEALTH COMPLAINTS. THESE WOMEN CLAIMED THAT (B)(6) DELETED THEIR REVIEWS AND TOLD THEM THEIR HEALTH INJURIES WERE NOT RELATED TO USING THE FASCIA BLASTER. AFTER READING OF ALL THIS, I FELT THE RISK WAS NOT WORTH IT. AFTER USING THIS PRODUCT FOR ONLY 3 WEEKS. I RETURNED ALL 3 FASCIA BLASTERS, OILS, ETC AT THE END OF (B)(6) 2017 AND RECEIVED A REFUND MINUS SHIPPING. APPROX 7 DAYS AFTER I STOPPED USING THE FASCIA BLASTER, STRANGE SYMPTOMS STARTED. THE FIRST DIAGNOSIS WAS A PINCHED NERVE-CERVICAL IN (B)(6) 2017. THE 2ND CONDITION WAS A BURST BLOOD VESSEL IN MY ILIOPSOAS MUSCLE AND INTERNAL BLEEDING INTO MY PELVIS ON (B)(6) 2017. A (B)(6) HOSPITAL VISIT TO MY MD RESULTED IN MY MD'S NOTIFICATION TO ME THAT THE FASCIA BLASTER CAUSED BOTH HEALTH CONDITIONS AND THAT I WAS TO NEVER USE AGAIN.