FDA.reportPublic FDA data

MAUDE MDR 6450615

MDR report key
6450615
Report number
MW5068797
Event key
0
Event type
3
Date of event
2017-03-03
Date received
2017-03-30
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
1ELECTRONIC MUSCLE STIMULATORSTIMULATOR, MUSCLE, POWEREDMIHA BODYTECIPFI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-03-3001. R

Event Narratives#

D

Patient 1

I AM A MEMBER OF (B)(6) ((B)(6)), AN EXCLUSIVE PRIVATE CLUB BASED IN (B)(6). THE CLUB HAS APPROXIMATELY 10 ELECTRONIC MUSCLE STIMULATION (EMS) DEVICES MANUFACTURED BY MIHA BODYTEC USED DURING PERSONAL TRAINING SESSIONS. I RECENTLY HAD A SESSION WITH THE (B)(6) PERSONAL TRAINER, (B)(6), AND HAVE SINCE EXPERIENCED SEVERE NERVE DAMAGE. I JUST LEARNED THAT THE EMS MACHINES THE (B)(6) USES HAVE NOT BEEN APPROVED BY THE FDA FOR SALE OR BUSINESS USE IN THE U.S. AS SUCH, THE DEVICES MUST HAVE BEEN ILLEGALLY IMPORTED SINCE THEY CANNOT BE PURCHASED IN THE U.S. MY CONCERN IS SOMEONE ELSE BEING SEVERELY INJURED OR WORSE. THE (B)(6) IS OPENLY MARKETING EMS SESSIONS TO ALL OF ITS MEMBERS.