MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-05 for ITOVI TRACKER / SCANNER manufactured by Itovi.
[113514120]
Product recall itovi is recalling the itovi scanner after it recently discovered that this device and its accessories may not have been manufactured according to current good mfg practices, including the 21 cfr 820 quality system regulation. In addition, three complainants have informed the company of alleged electrical shock when using the device. Although we were unable to reproduce the issue, itovi takes these allegations very seriously.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078276 |
| MDR Report Key | 7665753 |
| Date Received | 2018-07-05 |
| Date of Report | 2018-07-03 |
| Date Added to Maude | 2018-07-06 |
| 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 TRACKER / SCANNER |
| Generic Name | DEVICE GALVANIC SKIN RESPONSE MEASUREMENT |
| Product Code | GZO |
| Date Received | 2018-07-05 |
| Device Expiration Date | 2018-06-15 |
| 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 | 2018-07-05 |