QUELL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-31 for QUELL manufactured by Neurometrix Inc..

Event Text Entries

[90784434] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5073040
MDR Report Key6989914
Date Received2017-10-31
Date of Report2017-10-27
Date of Event2016-10-17
Date Added to Maude2017-10-31
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameQUELL
Generic NameTRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
Product CodeNUH
Date Received2017-10-31
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerNEUROMETRIX INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2017-10-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.