• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEUROMETRIX, INC. QUELL WEARABLE PAIN RELIEF STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NEUROMETRIX, INC. QUELL WEARABLE PAIN RELIEF STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER Back to Search Results
Model Number QE-001
Device Problems Fail-Safe Design Failure (1222); Inappropriate/Inadequate Shock/Stimulation (1574); Invalid Sensing (2293); Positioning Problem (3009)
Patient Problems Burn(s) (1757); Undesired Nerve Stimulation (1980); Discomfort (2330)
Event Date 01/02/2017
Event Type  Injury  
Event Description
The patient stated that he received this device on (b)(6) 2016 and began wearing it on his right leg that day. The patient reports that on (b)(6) 2017, he changed the electrodes because he believed that the electrodes dislodged from the proper position. The patient states that two weeks later on (b)(6) ,the patient was going to replace the electrodes when he noticed that there were 6-8 burn marks where the electrodes were placed. The patient then reports that he spoke with the manufacturer on the phone to report the issue, but was disappointed in how dismissive they seemed of the issue. The patient states that the next day on (b)(6), he was in a restaurant at the cashier when the device began to increase in shock amplitude and he began to feel discomfort similar to a shock. The patient then states that right before he was going to turn the device off, the device stopped stimulating him. The patient states that after 10 minutes, the device began doing the same thing, until finally the patient ripped it off his right leg. The patient reports that he contacted the manufacturer through the phone again to report this issue as well but, he mentions again how frustratingly dismissive the manufacturer seemed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameQUELL WEARABLE PAIN RELIEF
Type of DeviceSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
Manufacturer (Section D)
NEUROMETRIX, INC.
waltham MA
MDR Report Key6263050
MDR Text Key65433600
Report NumberMW5067307
Device Sequence Number1
Product Code NUH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberQE-001
Other Device ID NumberPATENT NO. 8, 948, 876
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/18/2017 Patient Sequence Number: 1
Treatment
TURMERIC.
-
-