BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

    MDR report key: 19977768 · Received August 13, 2024

    Report

    Report Number
    3003477176-2024-00024
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    February 26, 2024
    Report Date
    August 13, 2024
    Manufacturer
    UROMEDICA INC.
    Product Code
    EZY
    PMA / PMN Number
    P130018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PT. ENROLLED IN THE PROACT STUDY, PAS ENROLLMENT # (B)(6). PLAN FOR NEW DRAIN PLACEMENT AND ANTIBIOTIC THERAPY. ON (B)(6) 2024 IR DRAIN PLACED INTO LYMPHOCELE. (B)(6) 2024 IR INJECTION OF DYE INTO DRAIN. NO LEAKAGE OF LYMPHOCELE. SCLEROTHERAPY DONE. SOME INFLAMMATION NOTED AFTER PROCEDURE. ON (B)(6) 2024 CALLED BY PATIENT FOR A FEVER OF 101. WENT TO OUTSIDE ED. NON SEPTIC. CT SHOWS LYMPHOCELE. DISCHARGED ON CIPROFLOXACIN AND METRONIDAZOLE. (B)(6) 2024 SUBJECT HAD PICC LINE PLACED FOR ANTIBIOTIC TREATMENT. (B)(6) 2024 IR DRAIN REMOVED. ON (B)(6) 2024 PATIENT REPORTS HE IS DOING WELL.

    Description of Event or Problem · 0

    PT. REPORTS OVER THE LAST WEEK HE HAS HAD NEW ONSET OF CHILLS, MALAISE, AND FEVER FOLLOWING DRAIN REMOVAL ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682752 PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN PROACT EZY UROMEDICA INC. 800018-14 UM00859

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| O