MAUDE Adverse Event Report: NEUROMETRIX QUELL

Model Number QUELL

Device Problem Insufficient Information (3190)

Patient Problems Scarring (2061); Injury (2348); Blood Loss (2597)

Event Date 08/10/2015

Event Type  Injury  

Event Description

I had spine surgery and purchased a quell device from neurometrix.After 2 weeks of use i developed severe sores and bleeding around the electrode sites which has resulted in permanent scarring on my leg.

• Brand Name: QUELL
• Type of Device: QUELL
• Manufacturer (Section D): NEUROMETRIX
• MDR Report Key: 5221829
• MDR Text Key: 31195801
• Report Number: MW5057845
• 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: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/23/2015
• Device Model Number: QUELL
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 100