MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-14 for ITOVI TRACKER/SCANNER ITS10 - manufactured by Itovi.
| Report Number | 0000000000-2018-00101 |
| MDR Report Key | 7602534 |
| Date Received | 2018-06-14 |
| Date of Report | 2017-09-20 |
| Date of Event | 2017-09-20 |
| Date Mfgr Received | 2017-09-20 |
| Device Manufacturer Date | 2016-03-01 |
| Date Added to Maude | 2018-06-14 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MICHAEL WADMAN |
| Manufacturer Street | 355 S. 520 W SUITE 250 |
| Manufacturer City | LINDON 84042 |
| Manufacturer Country | US |
| Manufacturer Postal | 84042 |
| Manufacturer Phone | 8016150636 |
| Manufacturer G1 | ITOVI |
| Manufacturer Street | 355 SOUTH 520 WEST SUITE 250 |
| Manufacturer City | LINDON UT 84042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 0000000-06/08/18-001-R |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ITOVI TRACKER/SCANNER |
| Generic Name | GALVANIC SKIN RESPONSE MEASUREMENT DEVICE |
| Product Code | GZO |
| Date Received | 2018-06-14 |
| Model Number | ITS10 |
| Catalog Number | - |
| Lot Number | 032016 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ITOVI |
| Manufacturer Address | 355 SOUTH 520 WEST SUITE 250 LINDON UT 84042 US 84042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-14 |