MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-01 for M/N: ITOVI TRACKER IC:20864 - TOV 20021 manufactured by Itovi.
[116069136]
Received a recall notice for an itovi tracker. (b)(4) ic:20864-tov20021.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5078762 |
MDR Report Key | 7742230 |
Date Received | 2018-08-01 |
Date of Report | 2018-07-19 |
Date Added to Maude | 2018-08-02 |
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 | M/N: ITOVI TRACKER |
Generic Name | DEVICE GALVANIC SKIN RESPONSE MEASUREMENT |
Product Code | GZO |
Date Received | 2018-08-01 |
Model Number | IC:20864 - TOV 20021 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ITOVI |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2018-08-01 |