FDA.reportPublic FDA data

MAUDE MDR 8176327

MDR report key
8176327
Report number
MW5082256
Event key
0
Event type
3
Date of event
2018-08-28
Date received
2018-12-17
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
1EMGELECTROMYOGRAPH, DIAGNOSTICUNKIKNI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-1701. O; 2. S

Event Narratives#

D

Patient 1

I WAS TESTED BY AN EMG DEVICE AT MAXIMUM SETTING WHICH PUT ME INTO ELECTRO CONVULSIONS WHICH EVENTUALLY TORE MY BICEP MUSCLE NERVES TENDONS AT THE SITE WHERE MY PHONE HAD BROKEN 34 YEARS PREVIOUSLY WHICH PUT ME INTO SO MUCH PAIN. I ALMOST PASSED OUT. I HAVE NOT FELT THIS PAIN SO INTENSE IN 34 YEARS. THEY SHOULD HAVE A GOVERNOR ON THESE EMG MACHINES SO PEOPLE CANNOT ABUSE THEM, AND THERE SHOULD BE WARNING LABELS ON THE MACHINE AND IN THE BOOKLETS AN INSTRUCTION MANUAL SO THAT THE DR IS REMINDED AS WELL AS I WILL BE NOTIFIED THERE IS POSSIBLE DANGER INVOLVED. THIS EXPERIENCE WAS HORRENDOUS AND I CONSIDER IT TORTURE.