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

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.

• Brand Name: QUELL WEARABLE PAIN RELIEF
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
• Manufacturer (Section D): NEUROMETRIX, INC. ; waltham MA
• MDR Report Key: 6263050
• MDR Text Key: 65433600
• Report Number: MW5067307
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: QE-001
• Other Device ID Number: PATENT NO. 8, 948, 876
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: TURMERIC.
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 82