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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEUROMETRIX QUELL PAIN RELIEF NERVE STIMULATOR

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NEUROMETRIX QUELL PAIN RELIEF NERVE STIMULATOR Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Inadequate Pain Relief (2388)
Event Date 12/04/2016
Event Type  Injury  
Event Description
I began using the quell pain relief electrode band yesterday. I noticed some pain in my knee that i never had before. Today i had add'l pain in my shin. The pain occurred on the leg near where i wore the band. I stopped wearing the device and hope the pain will disappear completely soon. The pain is not bad, but definitely there.
 
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Brand NameQUELL PAIN RELIEF
Type of DeviceNERVE STIMULATOR
Manufacturer (Section D)
NEUROMETRIX
MDR Report Key6147520
MDR Text Key61614279
Report NumberMW5066545
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 12/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
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: 12/04/2016 Patient Sequence Number: 1
Treatment
CALCIUM; RECLAST; VITAMIN D.
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