MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-17 for ITOVI SCANNER ITS15 manufactured by Itovi, Llc.
[114413904]
Company is recalling itovi scanner as there have been some reports of electrical shock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078433 |
| MDR Report Key | 7697636 |
| Date Received | 2018-07-17 |
| Date of Report | 2018-07-13 |
| Date of Event | 2018-07-02 |
| Date Added to Maude | 2018-07-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ITOVI SCANNER |
| Generic Name | DEVICE, GALVANIC SKIN RESPONSE |
| Product Code | GZO |
| Date Received | 2018-07-17 |
| Model Number | ITS15 |
| Lot Number | 092017 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ITOVI, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-17 |