FDA.reportPublic FDA data

MAUDE MDR 5553729

MDR report key
5553729
Report number
MW5061504
Event key
0
Event type
3
Date of event
2016-03-26
Date received
2016-04-03
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 PULSE MASSAGERTENS UNITHEALTHMATE FOREVER LLCNGXYK15AB* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-04-0301. O

Event Narratives#

D

Patient 1

I HAVE RECEIVED SHOCK THERAPY AT A HEALTH CLINIC FOR CUBITAL TUNNEL SYNDROME. THEY SUGGESTED I GET A DEVICE WITH THE SAME SHOCK THERAPY CONCEPT. I GOT THIS BECAUSE IT WAS SUPPOSEDLY FDA APPROVED. THE FIRST AND LOWEST SETTING WAS ALREADY STRONGER AND PAINFUL TO USE. I GAVE IT THE BENEFIT OF THE DOUBT AND TRIED IT ON MY THIGH AND STILL THE LOWEST SETTING WAS TOO MUCH. MY WIFE TRIED THIS, (B)(6), AND SHE CRIED THE MOMENT IT WAS TURNED ON. THIS PRODUCT IS DANGEROUS AND I HAVE NO IDEA HOW IT HAS FDA APPROVAL OR THIS MANY SALES WITHOUT BEING SHUTDOWN. I HAVE HAD NERVE PAINS THAT HAVE BEEN LINGERING FOR 2 DAYS AFTER USING THAT PRODUCT.