BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM DELIVERY DEVICE KIT FOR BPH

    MDR report key: 8169887 · Received December 17, 2018

    Report

    Report Number
    3007795803-2018-00002
    Event Type
    Injury
    Date Received
    December 17, 2018
    Date of Event
    November 1, 2018
    Report Date
    November 27, 2018
    Manufacturer
    NXTHERA INC.
    Product Code
    KNS
    PMA / PMN Number
    K180237
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: THE EXACT EVENT DATE IS UNKNOWN. DATE RECEIVED BY MANUFACTURER: CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS POST CONVECTIVE RADIO FREQUENCY WATER VAPOR THERMAL THERAPY PROCEDURE TO TREAT A PATIENT'S PROSTATE, THE PATIENT HAD TO BE SCOPED DUE TO PERSISTENT IRRITATIVE VOIDING SYMPTOMS. THE CYSTOSCOPE PROCEDURE FOUND THAT THERE WAS A NOTICEABLE DIVOT IN THE MEDIAN LOB WHERE THE TREATMENT OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS POST CONVECTIVE RADIO FREQUENCY WATER VAPOR THERMAL THERAPY PROCEDURE TO TREAT A PATIENT'S PROSTATE, THE PATIENT HAD TO BE SCOPED DUE TO PERSISTENT IRRITATIVE VOIDING SYMPTOMS. THE CYSTOSCOPE PROCEDURE FOUND THAT THERE WAS A NOTICEABLE DIVOT IN THE MEDIAN LOB WHERE THE TREATMENT OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009880 REZUM DELIVERY DEVICE KIT FOR BPH VAPOR ABLATION SYSTEM KNS NXTHERA INC. D2201-C2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other