BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA BLUE

    MDR report key: 16487049 · Received March 6, 2023

    Report

    Report Number
    3003990090-2023-01551
    Event Type
    Injury
    Date Received
    March 6, 2023
    Date of Event
    August 1, 2022
    Report Date
    March 3, 2023
    Manufacturer
    CALDERA MEDICAL
    Product Code
    OTN
    UDI-DI
    00890594000650
    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 A RESULT OF (B)(4) STUDY, PATIENT REPORTED; DYSURIA ON (B)(6) 2022, TREATED WITH MACROBID AND IS CONSIDERED RESOLVED. CEC ADJUDICATED NOT RELATED TO DEVICE/PRODUCT. MENOPAUSAL VAGINAL DRYNESS ON (B)(6) 2022, CEC ADJUDICATED NOT RELATED TO DEVICE/PRODUCT. DRIBBLING ON (B)(6) 2022, CEC ADJUDICATED POSSIBLY RELATED TO DEVICE/PRODUCT, NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629903 DESARA BLUE DESARA BLUE OTN CALDERA MEDICAL L03018 00890594000650

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Other