BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 20251576 · Received September 18, 2024

    Report

    Report Number
    2124215-2024-58434
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    September 18, 2023
    Report Date
    September 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ENROLLED IN THE REZUM VAPEUR RCT STUDY ON 18SEP2023. ON 14JUN2023, THE PATIENT URINARY TRACT INFECTION (UTI) STATUS WAS NEGATIVE, AND HEMATURIA WAS NOT PRESENT. ON (B)(6) 2023, THE PATIENT UNDERWENT A WATER VAPOR THERAPY PROCEDURE UNDER ANESTHESIA. THE PATIENT WAS NOT PRESCRIBED ANTIBIOTICS. THE PATIENT RECEIVED THREE TREATMENTS IN THE RIGHT LOBE, AND THREE TREATMENTS IN THE LEFT LOBE. DURING THE PROCEDURE, THERE WERE NO ADVERSE EVENTS OR DEVICE MALFUNCTIONS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE SUBJECT WAS DISCHARGED WITH AN INDWELLING CATHETER, WHICH WAS REMOVED BY THE PHYSICIAN AT THE HOSPITAL ON (B)(6) 2023. ON (B)(6) 2023, 39 DAYS POST PROCEDURE, THE PATIENT EXPERIENCED A NON SERIOUS PAINFUL URINATION, WHICH WAS TREATED WITH XATRAL MEDICATION. THE EVENT RESOLVED ON 20FEB2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2464155 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION D2201 0030702704

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other