MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-07-10 for WITOUCH PRO 11.1500 manufactured by Hollywog, Llc.
[113620107]
The pt. (consumer) indicated he has atrial fibrillation from a preexisting condition. The warnings! Section of the instructions for use states: do not use this device if you are susceptible to rhythm disturbances to the heart unless under the direction of your physician. The pt. Stated he purchased the device on the internet without obtaining his physician's advice. He agreed not to continue using the device until he obtains advice from his physician. The pt. Stated he has used other manufacturers tens devices which he obtained through his physician at the (b)(6). The report was not a problem with the device, therefore, the device was not returned for evaluation. The dhr was reviewed which showed the device performed to specification when it was manufactured. There are no similar reports of atrial fibrilation from use of the device. The conclusion is this is an isolated event related to a pt. Preexisting condition and the pt. Did not read the warnings! Section of the instructions for use: do not use this device if you are susceptible to rhythm disturbances to the heart unless under the direction of your physician.
Patient Sequence No: 1, Text Type: N, H10
[113620108]
I purchased the device on (b)(6) and i experienced issues with my afib shortly after the first use of the device. I contacted my primary care physician at the (b)(6) to see if i can continue using the device. I will stop using the device until my doctor tells me if i can continue using the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008585473-2018-00106 |
| MDR Report Key | 7675654 |
| Report Source | CONSUMER |
| Date Received | 2018-07-10 |
| Date of Report | 2018-07-10 |
| Date of Event | 2018-07-09 |
| Date Added to Maude | 2018-07-10 |
| 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 | 4233057777 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WITOUCH PRO |
| Generic Name | TRANSCUTANEOUS ELECTRICAL NERVE STIMLUATOR FOR PAIN RELIEF |
| Product Code | NUH |
| Date Received | 2018-07-10 |
| Model Number | 11.1500 |
| Catalog Number | 11.1500 |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-07-10 |