BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 22469905 · Received July 10, 2025

    Report

    Report Number
    MW5172525
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    May 29, 2025
    Report Date
    July 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    APPROXIMATELY A MONTH AFTER THE REZUM PROCEDURE. I EXPERIENCE THE HEMORRHAGING OF BLOOD WHILE URINATING. AT A VERY HIGH RATE, AT WHICH TIME II RUSHED OFF TO THE LOCAL ER (B)(6), AND WAS TREATED WITH GRAVITY CBI (CONTINUOUS BLOOD IRRIGATION) FOR 30 PLUS HOURS. AND THEN TRANSFERRED OVER TO (B)(6) EMERGENCY ROOM. THEY DID A MECHANICAL CBI AND, WAS ADMITTED TO THE HOSPITAL FOR 2 DAYS, ONE NIGHT AND WAS RECEIVING GRAVITY CBI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894800 REZUM UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Hospitalization ALLOPURINOL| AMLODIPINE| IRON | LOSARTAN | LYRICA| METHOCARBAMOL | MONTELUKAST| OMEGA-3 ACID ETHYLESTERS| PREGABALIN | TADALAFIL| VITAMIN C AND D