WiTouch 11.1510Recalls & reported problems
Hollywog, LLC · WiTouch brand over the counter transcutaneous electrical nerve simulator for analgesic pain relief in the lower back · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00853096004014), received between Oct 13, 2016 and Jul 11, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Output Problem” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Output Problem2
Patient problems
- Undesired Nerve Stimulation2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 11, 2017Output Problem; Output Problem
THE CUSTOMER COMPLAINED THAT WHEN SHE PRESSED THE POWER BUTTON ON THE REMOTE CONTROL TO START THE TREATMENT, THE DEVICE GAVE HER A "JOLT" AND THEN STOPPED WORKING ALTOGETHER.
Patient problems: Undesired Nerve Stimulation
MAUDE report 6704027 ↗MalfunctionOct 13, 2016Output Problem; Output Problem
CUSTOMER HAS SPINAL STENOSIS AND HAS BEEN WEARING THE DEVICE FOR TWO WEEKS. THERE WERE NO PROBLEMS UNTIL (B)(6) 2016. SHE WAS WEARING THE UNIT ALL DAY AND IT HAD TURNED ITSELF OFF. CUSTOMER SAID SHE "GOT IN THE CAR TO GO SOMEWHERE AND ALL OF A SUDDEN IT LET OUT A CHARGE THAT TIGHTENED EVERY MUSCLE IN MY BODY AND CAUSED ME TO YELL OUT LOUD." SHE HAD HER REMOTE CONTROL AROUND HER NECK AND WAS ABLE TO DECREASE THE INTENSITY.
Patient problems: Undesired Nerve Stimulation
MAUDE report 6026815 ↗
Other Stimulator, Nerve, Transcutaneous, Over-The-Counter devices
- Aleve 1613538Bayer Healthcare LLC · Stimulator, Nerve, Transcutaneous, Over-The-Counter4 reports
- Enso M3Hinge Health, Inc. · Stimulator, Nerve, Transcutaneous, Over-The-Counter2 reports
- Roscoe Medical DT7202 / DT7202CADrive Devilbiss Healthcare · Stimulator, Nerve, Transcutaneous, Over-The-Counter1 report
- WiTouch Pro 11.1500Hollywog, LLC · Stimulator, Nerve, Transcutaneous, Over-The-Counter1 report
- AUVON AS8012-041Shenzhen Yuwen E-Commerce Co., Ltd. · 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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