BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA BLUE

    MDR report key: 16486487 · Received March 6, 2023

    Report

    Report Number
    3003990090-2023-01552
    Event Type
    Injury
    Date Received
    March 6, 2023
    Date of Event
    October 10, 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

    Narratives

    Description of Event or Problem · 0

    PER (B)(4) STUDY, IT WAS REPORTED; URINARY RETENTION REQUIRING CATHETERIZATION ON (B)(6) 2022. EVENT TREATED BY SUBJECT SELF-CATHETERIZING, AND PYRIDIUM AND BACTRIM. EVENT IS CONSIDERED RESOLVED. CEC ADJUDICATED EVENT POSSIBLY RELATED TO DEVICE/PRODUCT AND/OR PROCEDURE. URINARY TRACT INFECTION (B)(6) 2022, EVENT TREATED WITH CIPRO AND IS CONSIDERED RESOLVED. CEC ADJUDICATED NOT RELATED TO DEVICE/PRODUCT. WORSENING URGENCY ON (B)(6) 2022. EVENT HAS BEEN TREATED WITH OXYBUTYNIN CR AND MYRBETRIQ. CEC ADJUDICATED EVENT IS POSSIBLY RELATED TO DEVICE/PRODUCT. DYSURIA ON (B)(6) 2022, REQUIRED MEDICAL INTERVENTION AND IS RESOLVING. CEC ADJUDICATED EVENT IS POSSIBLY RELATED TO DEVICE/PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863849 DESARA BLUE DESARA BLUE OTN CALDERA MEDICAL N04041 00890594000650

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other| H