BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROACT

    MDR report key: 19671021 · Received July 3, 2024

    Report

    Report Number
    3003477176-2024-00020
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 3, 2024
    Report Date
    July 3, 2024
    Manufacturer
    UROMEDICA INC.
    Product Code
    EZY
    PMA / PMN Number
    P130018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT BEING TREATED FOR POSSIBLE INFECTION WITH ANTIBIOTICS. TREATMENT PLAN IS TO SEE HOW PATIENT RESPONDS TO ANTIBIOTICS.

    Description of Event or Problem · 0

    PATIENT CONTACTED UROMEDICA TO INFORM US HE THINKS HE HAS AN INFECTION ON HIS LEFT SIDE AND STATED HE BELIEVES HE HAS NO OTHER OPTION BUT TO HAVE ONE OR BOTH DEVICES REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478508 PROACT UROLOGOCAL IMPLANT EZY UROMEDICA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other