MAUDE Adverse Event Report: NEUROMETRIX INC. QUELL; TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problems Hypersensitivity/Allergic reaction (1907); Scar Tissue (2060); Tissue Damage (2104); Reaction (2414)

Event Date 10/17/2016

Event Type  Injury  

Event Description

Purchased quell product, fda approved.Used on legs, below knees as directed.Had nickel allergy, detected by self with cheap jewelry.Had no reason to believe nickel was used, still don't know.Had reaction, sm blisters on leg.No information on site about warnings.Even hair dye has warnings.Their customer service said use coconut oil for moisture, change legs.It was working for me.I was packing and moving and loved how it made me feel better.Have been on opiates for years.Ten plus, was hoping to lessen my break thru issues, which in my opinion very important to addiction and our current crisis.Anyway, i never slept with it, used intermittently, wore shorts, was careful.Something is not right with the disposable gel pads and leads.I have read the quality is not the best.After (b)(6) dollars and not covered by insurance, pay for pain pills instead, and lidocaine patches are not covered either, and they cost (b)(6) dollars for a month! yet salon pas, another company for otc lidocaine patches, sells a box of 6 for (b)(6) dollars at (b)(6).What gives.Chronic pain sufferers need alternatives as do the (b)(6) year old who wrenches his knee playing basketball.Anyway, i still have my quell machine as i wanted to go after this company for not printing warnings, not disclosing the real materials used and having a (b)(6) dollar an hour clerk giving bad information on (b)(4) group and on the phone.Advice given was try the other leg, moisturizer, rotate the band around your leg, use the app to see how long you used it - what am i stupid? their lack of knowledge and asking the (b)(4) audience for tips, is not responsible.I have pictures of the damage and scars to my legs.Not pretty.I am (b)(6) years old.Any questions please contact me.Thanks.The opioid crisis woke me up.I also have a son living in (b)(6), he uses heroin for 13 years and didn't start with pain pills or weed.I learned in 6th grade, that heroin was a monkey drug.One time and you're hooked - i never forget that.My son said he never heard of that.He was born in early (b)(6).I think during the dare era.He left (b)(4) for the streets of cold (b)(4)., as they expanded medicaid, 3 years ago.

• Brand Name: QUELL
• Type of Device: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
• Manufacturer (Section D): NEUROMETRIX INC.
• MDR Report Key: 6989914
• MDR Text Key: 90784434
• Report Number: MW5073040
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• 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: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 82