FDA.reportPublic FDA data

MAUDE MDR 7534329

MDR report key
7534329
Report number
MW5077396
Event key
0
Event type
3
Date of event
2017-02-28
Date received
2018-05-21
Adverse event
3
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
1EMG NERVE CONDUCTIONELECTROMYOGRAPH, DIAGNOSTICUNKIKNI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-2101. O

Event Narratives#

D

Patient 1

I HAD AN EMG NERVE CONDUCTION TEST THAT INJURED MY RIGHT CALF RESULTING IN A THERMAL BURN. I DID NOT OBSERVE THE MACHINE AS I WAS NOT EXPECTING ANYTHING TO HAPPEN. ON THE ONE RETURN VISIT, MY HUSBAND (AN ELECTRICAL ENGINEER) TOLD DR (B)(6) TO LET HIM SEE THE MACHINE, AS A RESULT HE TOLD DR (B)(6), THE MACHINE NEEDED TO BE CALIBRATED. MY REASON FOR SUBMITTING THIS REPORT IS THAT I WAS INJURED AT (B)(6) ON (B)(6) 2017. I HAD AN EMG-NERVE CONDUCTION STUDY. I FELT PAIN DURING THE TESTING AND ABOUT 1 HR AFTER THE TESTING I FELT BLISTERS SEVERE PAIN ON MY RIGHT CALF. I HAVE INCLUDED PICTURES OF MY INJURED LEG WITH THIS SUBMISSION. WHEN I GOT HOME I CALLED THE DEPARTMENT OF NEUROSCIENCE AND THEY HAD ME RETURN TO LOOK AT MY INJURY AND THEY CHOSE A DERMATOLOGIST TO CARE FOR MY INJURY. I HAVE INCLUDED THE DERMATOLOGIST REPORT WHICH DESCRIBES MY INJURY AS A THERMAL BURN AND DETAILS MY TREATMENTS. I AM NOT REPORTING THIS TO BESMIRCH ANYONE ALTHOUGH I FEEL LIKE I HAVE BEEN "SHOVED UNDER THE RUG." TO THIS DAY, I HAVE SEVERE PAIN IN MY RIGHT CALF ALL THE WAY DOWN TO THE ANKLE. I DO NOT WANT THIS TO HAPPEN TO ANYONE ELSE. THE REMARKS TO ME WERE UNUSUAL. A TECH THE FOLLOWING WEEK ON (B)(6) 2017 THAT PERFORMED MY CARPAL TUNNEL TEST SAW MY LEG AND REPLIED IN HIS OWN WORDS: "I HAVE NEVER SEEN ANYTHING LIKE THAT BEFORE." THE SAME DAY THE FLOOR MANAGER OF (B)(6) REPLIED IN HIS OWN WORDS: "ARE YOU SURE THIS HAPPENED HERE." THE ORDERING PHYSICIAN FOR THE EMG TESTING STATED ON HER REPORT THAT MY RIGHT LEG HAD DEVELOPED BLISTERS ALMOST IMMEDIATELY AFTER THE EMG/NCV. I HAVE HAD SO MANY REMARKS MADE TO ME ABOUT THIS SITUATION WONDERING WHY I DIDN'T HAVE BETTER ATTENTION TO THIS INJURY. IN MY OPINION, THERE WAS EITHER A MALFUNCTION OF THE MACHINE OF POSSIBLY THE OPERATION OF THE MACHINE. I HAD SEVERE BLISTERS THAT DEVELOPED INTO A PAINFUL SORE THAT TOOK 7 MONTHS TO HEAL. THERE REMAINS AN UGLY SCAR THAT IS STILL TENDER BENEATH THAT REGION. I HAVE MUSCLE PAIN DAILY. THANK YOU FOR REVIEWING MY SUBMISSION. I APPRECIATE YOUR TIME AND FEEDBACK. THERMAL BURN.