BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM DELIVERY DEVICE KIT FOR BPH

    MDR report key: 8149008 · Received December 10, 2018

    Report

    Report Number
    3007795803-2018-00001
    Event Type
    Injury
    Date Received
    December 10, 2018
    Date of Event
    October 17, 2018
    Report Date
    November 13, 2018
    Manufacturer
    NXTHERA INC.
    Product Code
    KNS
    PMA / PMN Number
    K180237
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT VISITED TREATING FACILITY FOR A FOLLOW-UP VISIT AFTER HOSPITALIST DISCUSSION REGARDING PENILE PAIN SINCE CONVECTIVE RADIO FREQUENCY WATER VAPOR THERMAL THERAPY PROCEDURE. THE PATIENT REPORTED THAT THE PENILE PAIN WAS SEVERE, INCAPACITATED, INTERMITTENT AND HAS REQUIRED MULTIPLE HOSPITALIZATIONS. CYSTOSCOPE PERFORMED SHOWED NO STRICTURE. THE PATIENT WAS PRESCRIBED IBUPROFEN AROUND THE CLOCK, URIBEL TWICE A DAY AND TRAMADOL FOR THE NIGHT. FOLLOW-UP VISIT APPROXIMATELY 20 DAYS POST REPORTED PENILE PAIN SYMPTOMS VISIT, THE PATIENT IS NO LONGER ON NSAIDS AND THE PAIN IS MOSTLY RESOLVED. THE PATIENT REMAINS ON URIBEL FOUR TIMES A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985850 REZUM DELIVERY DEVICE KIT FOR BPH VAPOR ABLATION SYSTEM KNS NXTHERA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| O