MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-27 for ITOVI SCANNER manufactured by Itovi.
[122180689]
Recall. The product is over-the-counter. The problem stopped after the person started taking or using the product again. The problem returned if the person started taking or using the product again. The product was used on skin. Therapy duration: 2 months. Reason for use: personal scan.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080187 |
| MDR Report Key | 7918710 |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-26 |
| Date Added to Maude | 2018-09-28 |
| 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 MEASUREMENT |
| Product Code | GZO |
| Date Received | 2018-09-27 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ITOVI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-27 |