EMG NERVE CONDUCTION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-21 for EMG NERVE CONDUCTION manufactured by Unk.

Event Text Entries

[108988579] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5077396
MDR Report Key7534329
Date Received2018-05-21
Date of Report2018-05-08
Date of Event2017-02-28
Date Added to Maude2018-05-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEMG NERVE CONDUCTION
Generic NameELECTROMYOGRAPH, DIAGNOSTIC
Product CodeIKN
Date Received2018-05-21
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-05-21

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