MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-16 for WITOUCH PRO 11.1500 manufactured by Hollywog, Llc.
| Report Number | 3008585473-2019-00003 |
| MDR Report Key | 8796178 |
| Date Received | 2019-07-16 |
| Date of Report | 2019-07-16 |
| Date of Event | 2018-04-09 |
| Date Mfgr Received | 2019-07-12 |
| Date Added to Maude | 2019-07-16 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MICHAEL TREAS |
| Manufacturer Street | 100 CHEROKEE BOULEVARD SUITE 123 |
| Manufacturer City | CHATTANOOGA TN 37405 |
| Manufacturer Country | US |
| Manufacturer Postal | 37405 |
| Manufacturer Phone | 4233057777 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WITOUCH PRO |
| Generic Name | TRANSCUTANEOUS ELECTRICAL NERVE SIMULATOR |
| Product Code | NUH |
| Date Received | 2019-07-16 |
| Catalog Number | 11.1500 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLYWOG, LLC |
| Manufacturer Address | 100 CHEROKEE BOULEVARD SUITE 123 CHATTANOOGA TN 37405 US 37405 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-07-16 |