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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEUROMETRIX, INC. QUELL; STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
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NEUROMETRIX, INC. QUELL; STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER Back to Search Results
Device Problems Failure to Read Input Signal (1581); Failure to Shut Off (2939)
Patient Problem Pain (1994)
Event Date 06/05/2019
Event Type  Injury  
Event Description
I was using a quell nerve stimulator on my calf as directed.It suddenly started increasing in intensity and becoming painful.When i opened the app, it said "calibrating" and wouldn't shut it off.I tried to use the shut off button on the device itself (and pressed it four times as directed for shut off).That didn't work either and it kept increasing to the point that it was causing blinding pain.I tried several times to turn it off and finally had to remove it with my hands, which caused severe pain on my fingers.Customer service stated that i probably started the calibration myself by accidentally pushing the button.This is possible but unlikely; however, the calibration sessions i've done before felt nothing like this (they were light tingles vs constantly increasing intensity), the screen shown on the app was different and non responsive, and there was no way to stop the stimulation.Serious pain.Fda safety report id# (b)(4).
 
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Brand Name
QUELL
Type of Device
STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
Manufacturer (Section D)
NEUROMETRIX, INC.
MDR Report Key8683162
MDR Text Key147559586
Report NumberMW5087209
Device Sequence Number0
Product Code NUH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age34 YR
Patient Weight68
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