MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-07-11 for WITOUCH 11.1510 manufactured by Hollywog, Llc.
[79727942]
The dhr review shows the device performed as intended when it was manufactured. The tens device and handheld remote control were able to power on. The device output treatment frequencies were to specification, however, the waveform was not to specification. The device is will be evaluated by the design engineers for root cause of the waveform not performing to specification. The device labeling was reviewed and found to be suitable and adequate for the device to perform its intended use.
Patient Sequence No: 1, Text Type: N, H10
[79727943]
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 Sequence No: 1, Text Type: D, B5
| Report Number | 3008585473-2017-00010 |
| MDR Report Key | 6704027 |
| Report Source | CONSUMER |
| Date Received | 2017-07-11 |
| Date of Report | 2017-06-07 |
| Date of Event | 2017-05-06 |
| Date Mfgr Received | 2017-05-12 |
| Device Manufacturer Date | 2015-08-31 |
| Date Added to Maude | 2017-07-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MICHAEL TREAS |
| Manufacturer Street | 2830 AMNICOLA HIGHWAY |
| Manufacturer City | CHATTANOOGA TN 374063605 |
| Manufacturer Country | US |
| Manufacturer Postal | 374063605 |
| Manufacturer Phone | 4233057778 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WITOUCH |
| Generic Name | OVER THE COUNTER TRANSCUTANEOUS ELECTRICAL NERVE STIMLUATOR |
| Product Code | NUH |
| Date Received | 2017-07-11 |
| Returned To Mfg | 2017-05-22 |
| Model Number | 11.1510 |
| Catalog Number | 11.1510 |
| Device Availability | R |
| Device Age | 22 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLYWOG, LLC |
| Manufacturer Address | 2830 AMNICOLA HIGHWAY CHATTANOOGA TN 374063605 US 374063605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-07-11 |