MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-10-13 for WITOUCH 11.1510 manufactured by Hollywog, Llc.
[57332605]
The dhr review shows the device performed as intended when it was manufactured. During evaluation the device and device remote were found in poor condition. The device and device remote control were able to power on. The device treatment was able to function to specification, frequencies were to specification. The device labeling was reviewed and found to be suitable and adequate for the device to perform its intended use. The device performed to specification.
Patient Sequence No: 1, Text Type: N, H10
[57332606]
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 Sequence No: 1, Text Type: D, B5
| Report Number | 3008585473-2016-00620 |
| MDR Report Key | 6026815 |
| Report Source | CONSUMER |
| Date Received | 2016-10-13 |
| Date of Report | 2016-10-13 |
| Date of Event | 2016-09-07 |
| Date Mfgr Received | 2016-09-13 |
| Date Added to Maude | 2016-10-13 |
| 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 | 2016-10-13 |
| Returned To Mfg | 2016-09-19 |
| Model Number | 11.1510 |
| Catalog Number | 11.1510 |
| Device Availability | R |
| Device Age | 10 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 | 2016-10-13 |