BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA ONE

    MDR report key: 16486532 · Received March 6, 2023

    Report

    Report Number
    3003990090-2023-01557
    Event Type
    Injury
    Date Received
    March 6, 2023
    Date of Event
    November 10, 2022
    Report Date
    March 5, 2023
    Manufacturer
    CALDERA MEDICAL
    Product Code
    PAH
    UDI-DI
    00890594000971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PER (B)(4) STUDY, PATIENT REPORTED; PERSISTENT STRESS INCONTINENCE ON (B)(6) 2022. POP-Q, UA, AND VITALS ASSESSED. EVENT WAS LISTED AS RECOVERING/RESOLVING FOLLOWING INTERVENTION (OXYBUTYNIN) WORSENING URGE INCONTINENCE ON (B)(6) 2022. POP-Q, UA, AND VITALS ASSESSED. EVENT WAS LISTED AS RECOVERING/RESOLVING FOLLOWING INTERVENTION (OXYBUTYNIN) CAUSE OF EVENT IS UNDECIDED, CEC REVIEWING RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629872 DESARA ONE DESARA ONE PAH CALDERA MEDICAL CAL-DS2113 N05041 00890594000971

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Other