BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 24598644 · Received March 13, 2026

    Report

    Report Number
    2124215-2026-14197
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    January 1, 2026
    Report Date
    April 13, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729992547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED BASED ON SHIP HISTORY FOR THE DEVICES SENT TO CUSTOMER, AND IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE INSTRUCTIONS FOR USE (IFU) WAS REVIEWED. THE PATIENT SYMPTOM INCONTINENCE, URINARY WAS FOUND TO BE LISTED IN THE IFU. A REVIEW OF THE REZUM HAZARD ANALYSIS WAS COMPLETED AND CONFIRMED THAT THE EVENT OF INCONTINENCE, URINARY WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. BASED ON ALL AVAILABLE INFORMATION, AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. G4: PMA/510(K) # FIELD ON 3500A FORM IS K190093, K191505 - REPORTED HERE AS PMA # EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD.

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K) # FIELD ON 3500A FORM IS K190093, K191505 - REPORTED HERE AS PMA # EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD PREVIOUSLY UNDERWENT A CONVECTIVE RADIOFREQUENCY WATER VAPOR THERMAL THERAPY, AND NOW THE PATIENT IS EXPERIENCING URINARY INCONTINENCE. IT IS BELIEVED THAT THE EITHER THE DEVICE OR THE TECHNIQUE CONTRIBUTED TO THE SYMPTOM EXPERIENCED BY THE PATIENT. A CATHETER WAS USED BUT THE ISSUE IS STILL ONGOING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD PREVIOUSLY UNDERWENT A CONVECTIVE RADIOFREQUENCY WATER VAPOR THERMAL THERAPY, AND NOW THE PATIENT IS EXPERIENCING URINARY INCONTINENCE. IT IS BELIEVED THAT THE EITHER THE DEVICE OR THE TECHNIQUE CONTRIBUTED TO THE SYMPTOM EXPERIENCED BY THE PATIENT. A CATHETER WAS USED BUT THE ISSUE IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158363 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M006D2201-003 08714729992547

    Patients

    Seq Age Sex Outcome Treatment
    1