AUVON AS8012-041Recalls & reported problems
Shenzhen Yuwen E-Commerce Co., Ltd. · Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06971292001201), received between Jan 13, 2021 and Jan 13, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Excessive Heating” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Excessive Heating1
Patient problems
- Burn, Thermal1
- Erythema1
- Hypersensitivity/Allergic reaction1
- Itching Sensation1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 13, 2021Excessive Heating
PRODUCT NAME IS AUVON DUAL CHANNEL TENS UNIT MUSCLE STIMULATOR MACHINE? MODEL NO. AS8012; I BOUGHT IT ON (B)(6), THE LINK IS: (B)(6) PROBLEM: I GOT A SHARP PAIN WHEN I AM USING THE TENS UNIT AND SAW THE PADS LEFT MILD BURNS ON MY SKIN. IT IS LIKE ALLERGY SYMPTOMS AND THE SKIN WAS ITCHING AND REDNESS FOR SEVERAL DAYS AND RECOVERED IF I STOPPED USING IT. BUT IF I RESTART USING IT, IT LEFT BURNS ON THE SKINS AGAIN. COMPANY NAME IS SHENZHEN YUWEN E-COMMERCE CO., LTD. MANUFACTURER: SHENZHEN AS-TEC TECHNOLOGY CO, LTD. FDA SAFETY REPORT ID # (B)(4).
Patient problems: Burn, Thermal; Erythema; Hypersensitivity/Allergic reaction; Itching Sensation; Pain
MAUDE report 11170158 ↗
Other Stimulator, Nerve, Transcutaneous, Over-The-Counter devices
- Aleve 1613538Bayer Healthcare LLC · Stimulator, Nerve, Transcutaneous, Over-The-Counter4 reports
- WiTouch 11.1510Hollywog, LLC · Stimulator, Nerve, Transcutaneous, Over-The-Counter2 reports
- Enso M3Hinge Health, Inc. · Stimulator, Nerve, Transcutaneous, Over-The-Counter2 reports
- WiTouch Pro 11.1500Hollywog, LLC · Stimulator, Nerve, Transcutaneous, Over-The-Counter1 report
- Roscoe Medical DT7202 / DT7202CADrive Devilbiss Healthcare · Stimulator, Nerve, Transcutaneous, Over-The-Counter1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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