BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

    MDR report key: 22977380 · Received September 5, 2025

    Report

    Report Number
    3003477176-2025-00012
    Event Type
    Injury
    Date Received
    September 5, 2025
    Date of Event
    July 8, 2025
    Report Date
    September 4, 2025
    Manufacturer
    UROMEDICA, INC.
    Product Code
    EZY
    PMA / PMN Number
    P130018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ADDITIONAL NOTE IS IN REGARD TO THE TIMING OF THIS REPORT. THE PREVIOUS REGULATORY REPORTER FOR UROMEDICA, INC. ORIGINALLY CREATED THE REPORT FOR THIS EVENT (VIA ESUBMITTER) ON (B)(6) 2025 BUT DID NOT SUBMIT THE REPORT VIA THE ESG PORTAL TO CDRH. THIS PERSON HAD A SUDDEN MEDICAL EMERGENCY AND DROPPED OUT OF CONTACT WITH UROMEDICA, INC, AS OF THE FIRST WEEK OF (B)(6), RESULTING IN THE DELAYED SUBMISSION OF THIS REPORT.

    Description of Event or Problem · 0

    PATIENT'S RIGHT BALLOON BURST. EXPLANTED RIGHT BALLOON AND DURING CYSTOSCOPY NOTICED THAT THE PATIENT'S LEFT BALLOON WAS VISIBLE UNDER CYSTO AND HAD ERODED SO EXPLANTED LEFT BALLOON AS WELL. CATHETER PLACED, WILL COME BACK FOR BILATERAL PROACT PLACEMENT SOMETIME IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2131809 PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN PROACT EZY UROMEDICA, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other