BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM DELIVERY DEVICE KIT FOR BPH

    MDR report key: 8175579 · Received December 18, 2018

    Report

    Report Number
    3007795803-2018-00004
    Event Type
    Injury
    Date Received
    December 18, 2018
    Date of Event
    December 1, 2018
    Report Date
    December 3, 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

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: THE EXACT EVENT DATE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 10 WEEKS POST CONVECTIVE RADIO FREQUENCY WATER VAPOR THERMAL THERAPY PROCEDURE OF THE PROSTATE, THE PATIENT HAS TERRIBLE DYSURIA. CYSTOSCOPY PERFORMED BY THE PHYSICIAN, SHOWED THERE WAS A "FLAP" OF TISSUE. THE PHYSICIAN REPORTED THAT THE TISSUE IS POSSIBLY ATTACHED AND THAT IS NECROTIC AND PARTIALLY IN THE BLADDER CAUSING OBSTRUCTION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013238 REZUM DELIVERY DEVICE KIT FOR BPH VAPOR ABLATION SYSTEM KNS NXTHERA INC. D2201-C2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other