MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-08-29 for ITOVI SCANNER ITS15 manufactured by Itovi.
[119036896]
Specification developer and finished product manufacturer establishment: itovi (b)(4). Classification name: device, galvanic skin response measurement product code: gzo. Device class: 2. (b)(4). Medical specialty: neurology. Registered establishment name: itovi. Owner/operator: itovi. (b)(4). Establishment operations: manufacturer. Complaint file establishment for specification developer and finished product manufacturer establishment: hudson scientific llc. (b)(4) status: active. *note firm may have additional establishment types. Please review listings for further information. Date of registration status: 2018. Owner/operator: hudson scientific llc (b)(4). Establishment operations: complaint file establishment. Specification developer and finished product manufacturer is in the process of redesigning a new medical device for subsequent replacement.
Patient Sequence No: 1, Text Type: N, H10
[119036897]
(b)(6) received email on the 31st day of july, 2018: customer says granddaughter was shocked. Customer report routed to (b)(4). (b)(4) responded to customer and customer repeated that granddaughter was shocked last (b)(4). Customer report routed to (b)(4). (b)(4) received an email on the 7th day of august, 2018 asking for a refund because of shock to granddaughter. (b)(4) responded to customer on the 17th day of august to inform her that itovi has opened an investigation into the account and would not be able to give a refund at this time. Agreed to stay in touch to resolve complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014545134-2018-00106 |
| MDR Report Key | 7826616 |
| Report Source | CONSUMER |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-27 |
| Date of Event | 2017-11-23 |
| Date Mfgr Received | 2018-07-31 |
| Date Added to Maude | 2018-08-29 |
| 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 UT 84042 |
| Manufacturer Country | US |
| Manufacturer Postal | 84042 |
| Manufacturer Phone | 8016150636 |
| Manufacturer G1 | ITOVI |
| Manufacturer Street | 355 S. 520 W SUITE 250 |
| Manufacturer City | LINDON UT 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 SCANNER |
| Generic Name | ITOVI SCANNER |
| Product Code | GZO |
| Date Received | 2018-08-29 |
| Model Number | ITS15 |
| Lot Number | UNKNOWN |
| 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 S. 520 W SUITE 250 LINDON UT 84042 US 84042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-29 |