FDA Adverse Event
Summary report: N
VIVOO
MDR report key: 12787568
·
Received November 9, 2021
Report
- Report Number
- MW5105238
- Date Received
- November 9, 2021
- Report Date
- November 7, 2021
- Manufacturer
- VIVOSENS BIYOTEKNOLOJI AR-GE, SAN. & TIC. LTD. STI
- Product Code
- LJX
- Report Source
- Voluntary report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT REPORTED HAVING A UTI BASED ON THE RESULTS THEY RECEIVED FROM AN APP. REPEAT TESTING IN CLINIC DID NOT SHOW ANY EVIDENCE OF UTI. AFTER REVIEWING THE APP, IT APPEARS LIKE THIS PRODUCT DOES NOT HAVE FDA APPROVAL AND IS INAPPROPRIATELY PROVIDING MEDICAL DIAGNOSIS. WEBSITE: (B)(6). FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1675625 | VIVOO | TEST, URINE LEUKOCYTE | LJX | VIVOSENS BIYOTEKNOLOJI AR-GE, SAN. & TIC. LTD. STI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |