MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-07-09 for ITOVI TRACKER ITS10 - manufactured by Itovi.
[113464259]
Specification developer and finished product manufacturer: establishment: itovi (b)(4). Status: active; awaiting assignment of registration number. Date of registration status: 2018. Owner/operator: itovi (b)(4). Proprietary name: itovi. Classification name: device, galvanic skin response measurement. Product code: gzo. Device class: 2. Regulation number: (b)(4). Medical specialty: neurology. Registered establishment name: itovi. Owner/operator: itovi. Owner/operator number: (b)(4). Establishment operations: manufacturer. Complaint file establishment for ivovi: (b)(4). Status: active. Initial distributor/importer: no. Note firm may have additional establishment types. Please review listings for further information. Date of registration status: 2018. Owner/operator: (b)(4). Owner/operator number: (b)(4). Official correspondent: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[113464260]
Via an e-mail to the finished product manufacturer/ specification developer on (b)(6) 2018, the complainant reported that on/around (b)(6) 2018, he received a blood blister when using the itovi device (i. E. While scanning and unplugged from a power source). The finished product manufacturer/ specification developer requested the unit to be returned back for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014545134-2018-00102 |
| MDR Report Key | 7670538 |
| Report Source | CONSUMER |
| Date Received | 2018-07-09 |
| Date of Report | 2018-04-10 |
| Date of Event | 2018-04-09 |
| Date Mfgr Received | 2018-04-09 |
| Device Manufacturer Date | 2016-03-01 |
| Date Added to Maude | 2018-07-09 |
| 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 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 S. 520 W SUITE 250 |
| Manufacturer City | LINDON 84042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84042 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 0000000-06/08/18-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ITOVI TRACKER |
| Generic Name | GALVANIC SKIN RESPONSE MEASUREMENT DEVICE, PRODUCT CODE: GZO |
| Product Code | GZO |
| Date Received | 2018-07-09 |
| Returned To Mfg | 2018-04-30 |
| Model Number | ITS10 |
| Catalog Number | - |
| Lot Number | 032016 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ITOVI |
| Manufacturer Address | 355 S. 520 W SUITE 250 LINDON 84042 US 84042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-09 |