FDA.reportPublic FDA data

MAUDE MDR 6913986

MDR report key
6913986
Report number
MW5072591
Event key
0
Event type
3
Date of event
2017-04-24
Date received
2017-10-04
Adverse event
0
Product problem
0
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
1FASCIABLASTERFASCIABLASTERADB INTERESTS, LLCIODI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-10-040

Event Narratives#

D

Patient 1

I PURCHASED THE FASCIABLASTER FROM ASHLEYBLACKGURU.COM IN (B)(6) OF 2016. I USED THE DEVICES FOR 6 MONTHS AND GOT VERY ILL WITH CHRONIC FATIGUE, GI ISSUES, PAIN AND MY SKIN NOW IS WRINKLED IN NEW PLACES AND I HAVE CELLULITE WHERE I HAD NONE BEFORE. INCIDENT LOCATION: (B)(6), UNITED STATES. THIS IS MY HOME ADDRESS. THE FASCIABLASTER IS ADVERTISED TO CURE CELLULITE, IMPROVE RANGE OF MOTION AND LESSEN JOINT PAIN - I BOUGHT IT FOR PAIN RELIEF, THEN USED IT ON MY ABDOMEN FOR AESTHETIC PURPOSES. PRODUCT CATEGORY: PERSONAL CARE. RETAILER: ASHLEYBLACKGURU.COM. RETAILER STATE: (B)(6). PURCHASE DATE: (B)(6) 2016 THIS DATE IS AN ESTIMATE. I STILL HAVE THE PRODUCT IN MY POSSESSION: NO. THE PRODUCT WAS DAMAGED BEFORE THE INCIDENT: NO. THE PRODUCT WAS MODIFIED BEFORE THE INCIDENT: NO. HAVE YOU CONTACTED THE MANUFACTURER: YES. EXPLANATION: I REACHED OUT TO THEM SEVERAL TIMES IN THE 6 MONTHS I WAS USING IT, BUT NEVER HEARD BACK FROM THEM.