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 SCANNER ITS15 manufactured by Itovi.
[113499168]
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). Official correspondent: (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; [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[113499169]
From (b)(6) 2018- (b)(6) 2018, there were various discussions between the complainant and the formally designated complaint unit from the finished product manufacturer/ specification developer. During initial discussions on (b)(6) 2018, the complainant alleged to itovi's (the finished product manufacturer/ specification developer) formally designated complaint unit ((b)(4)) that on (b)(6) 2018, she (adult female) received an electric shock and heart palpitations (which also caused her to be passed out for an unknown amount of time also on (b)(6) 2018) while using the itovi device (i. E while scanning and having the unit be plugged into a power source). On (b)(6) 2018, the complainant sought medical attention due to the electric shock and heart palpitations. The subsequent (b)(6) 2018 medical record (copy supplied by the complainant) indicated that the complainant (who was alert and oriented three times) had lessening palpitations from the time of the incident, the complainant had no chest pain, coughing, dizziness, fever, malaise/fatigue, nausea, shortness of breath, vomiting or weakness during the (b)(6) 2018 medical examination. However, the medical record did not indicate whether the complainant required hospitalization and/or treatment for the alleged electric shock and heart palpitations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014545134-2018-00103 |
| MDR Report Key | 7670512 |
| Report Source | CONSUMER |
| Date Received | 2018-07-09 |
| Date of Report | 2018-01-10 |
| Date of Event | 2018-01-10 |
| Date Mfgr Received | 2018-01-11 |
| Device Manufacturer Date | 2017-09-01 |
| 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 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ITOVI SCANNER |
| Generic Name | GALVANIC SKIN RESPONSE MEASUREMENT DEVICE, PRODUCT CODE: GZO |
| Product Code | GZO |
| Date Received | 2018-07-09 |
| Returned To Mfg | 2018-05-07 |
| Model Number | ITS15 |
| Lot Number | 092017 |
| 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 SOUTH 520 WEST SUITE 250 LINDON 84042 US 84042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-09 |