MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-05 for ITOVI SCANNER manufactured by Itovi.
[113513884]
Got a zap from the scanner. "suspect: yes; primary: yes; did the problem stop after the person reduced the dose or stopped taking or using the product: yes. "
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5078263 |
MDR Report Key | 7665740 |
Date Received | 2018-07-05 |
Date of Report | 2018-07-02 |
Date of Event | 2018-04-04 |
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 SCANNER |
Generic Name | DEVICE, GALVANIC SKIN RESPONSE MEASUREMENT |
Product Code | GZO |
Date Received | 2018-07-05 |
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 |