BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 19174144 · Received April 23, 2024

    Report

    Report Number
    MW5154167
    Event Type
    Injury
    Date Received
    April 23, 2024
    Date of Event
    December 30, 2023
    Report Date
    April 20, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REZUM, 510(K): K150786 PRODUCT. HAD REZUM DONE IN (B)(6) ON (B)(6) 2023 AT (B)(6) SURGICAL CENTER. INFECTION, EPIDIDYMITIS, 2 MONTHS IN BED, STARTING (B)(6) 2024, NO SPERM ON EJACULATION. WAS NOT TOLD THIS COULD HAPPEN BECAUSE OF PROCEDURE, LOOKED IT UP SAME IN UK. I'M GOING TO POST ALL OF THIS DIDN'T HAVE KNOWLEDGE OF THESE PROBLEMS, NO SPERM, NO ORGASMIC FEELING JUST CLEAR PROSTATE FLUID, I WANT THIS FIXED, IT'S LIKE YOU ARE CASTRATED BUT STILL HAVE TESTICLES. I'M (B)(6). REZUM UNDER 510(K): K150786 PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145683 REZUM UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Disability| O