QUELL WEARABLE PAIN RELIEF QE-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-18 for QUELL WEARABLE PAIN RELIEF QE-001 manufactured by Neurometrix, Inc..

Event Text Entries

[65433600] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5067307
• MDR Report Key: 6263050
• Date Received: 2017-01-18
• Date of Report: 2017-01-18
• Date of Event: 2017-01-02
• Date Added to Maude: 2017-01-19
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: QUELL WEARABLE PAIN RELIEF
• Generic Name: STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
• Product Code: NUH
• Date Received: 2017-01-18
• Model Number: QE-001
• ID Number: PATENT NO. 8, 948, 876
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NEUROMETRIX, INC.
• Manufacturer Address: WALTHAM MA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-01-18