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 N/A manufactured by Itovi.
[118774923]
On the (b)(4) 2018 (b)(4) received a customer email; customer emailed itovi requesting the recall form, but also mentioned that on of her clients were shocked by the device. Email routed to (b)(4). On the (b)(4) 2018 (b)(4) received a customer email; customer claims a teenager that they scanned was shocked twice, but that she didn't think much of it. Email routed to (b)(4). Specification developer and finished product manufacturer: establishment: (b)(4). Classification name: device, galvanic skin response measurement, product code: gzo, device class: 2, regulation number: (b)(4), medical specialty: neurology, registered establishment name: itovi. (b)(4). Establishment operations: manufacturer. Complaint file establishment for specification developer and finished product manufacturer (b)(4). Status: active. Note firm may have additional establishment types. Please review listings for further information. Date of registration status: 2018. (b)(4). 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
[118774924]
On the (b)(4) 2018 (b)(4) received a customer email; customer emailed itovi requesting the recall form, but also mentioned that one of her clients were shocked by the device. Email routed to (b)(4). On the (b)(4) 2018 (b)(4) received a customer email; customer claims a teenager that they scanned was shocked twice, but that she didn't think much of it. Email routed to (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014545134-2018-00105 |
| MDR Report Key | 7826614 |
| Report Source | CONSUMER |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-08-10 |
| Date Mfgr Received | 2018-08-10 |
| 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 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 |
| Product Code | GZO |
| Date Received | 2018-08-29 |
| Model Number | ITS15 |
| Catalog Number | N/A |
| 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 84042 US 84042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-29 |