MAUDE Adverse Event Report: NEUROMETRIX QUELL PAIN RELIEF; NERVE STIMULATOR

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.

• Brand Name: QUELL PAIN RELIEF
• Type of Device: NERVE STIMULATOR
• Manufacturer (Section D): NEUROMETRIX
• MDR Report Key: 6147520
• MDR Text Key: 61614279
• Report Number: MW5066545
• Device Sequence Number: 1
• Product Code: NUH
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 12/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CALCIUM; RECLAST; VITAMIN D.
• Patient Age: 65 YR
• Patient Weight: 53