BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA BLUE

    MDR report key: 16486538 · Received March 6, 2023

    Report

    Report Number
    3003990090-2023-01549
    Event Type
    Injury
    Date Received
    March 6, 2023
    Date of Event
    November 8, 2022
    Report Date
    March 3, 2023
    Manufacturer
    CALDERA MEDICAL
    Product Code
    OTN
    UDI-DI
    00890594000667
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AS PART OF (B)(4) STUDY, PATIENT REPORTED; UTI ON (B)(6) 2022, EVENT TREATED WITH AZO (PRN, MACROBID, AND LEVAQUIN, CEC ADJUDICATED NOT RELATED TO PRODUCT. WORSENED PROLASPE ON (B)(6) 2022 AND IS CONSIDERED ONGOING. CEC ADJUDICATED NOT RELATED TO PRODUCT. DYSURIA ON DECEMBER (B)(6) 2022, EVENT TREATED WITH MACROBID. CEC REQUESTED MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629878 DESARA BLUE DESARA BLUE OTN CALDERA MEDICAL M10009 00890594000667

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other