BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BULKAMID(R) URETHRAL BULKING SYSTEM

    MDR report key: 10843109 · Received November 16, 2020

    Report

    Report Number
    3005111102-2020-00001
    Event Type
    Injury
    Date Received
    November 16, 2020
    Date of Event
    February 17, 2020
    Report Date
    November 13, 2020
    Manufacturer
    CONTURA INTERNATIONAL A/S
    Product Code
    LNM
    PMA / PMN Number
    P170023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONTURA CONCLUDES THAT UROSEPSIS IS RELATED TO THE UTI. THE PATIENT HAD A POSITIVE URINE STIX PRIOR TO THE PROCEDURE. UTI IS CONTRAINDICATED ACCORDING TO THE IFU. THE UTI MAY POSSIBLY BE RELATED TO THE BULKING PROCEDURE AS UTI IS A KNOWN COMPLICATION OF CYSTOSCOPY PROCEDURES. THE BULKAMID INSTRUCTION FOR USE (IFU) INCLUDES A WARNING ABOUT USING THE PRODUCT IN CASE OF AN ACTIVE INFECTION. FURTHERMORE THE IFU INFORMS THAT UTI CAN BE A POSSIBLE COMPLICATION AFTER THE PROCEDURE AND TREATMENT WITH ANTIBIOTICS PRIOR TO THE PROCEDURE IS MANDATED. THIS PATIENT HAS A PRIOR HISTORY OF UTI WITH COMPLICATIONS AND WAS NOT GIVEN ANTIBIOTICS PRIOR TO THE PROCEDURE.

    Description of Event or Problem · 1

    PATIENT RECEIVED TREATMENT WITH BULKAMID ON FRIDAY (B)(6) 2020. ON (B)(6) 2020 THE PATIENT PRESENTED WITH UROSEPSIS AND SEPTIC SHOCK, HEMATURIA AND LOW BLOOD PRESSURE. PATIENT WAS ADMITTED AND RECEIVED IV ANTIBIOTICS, PHENYEPHRINE AND 3-WAY BLADDER IRRIGATION. CT SCAN SHOWED NO KIDNEY DAMAGE. TREATMENT TOOK 48 HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313449 BULKAMID(R) URETHRAL BULKING SYSTEM BULKAMID LNM CONTURA INTERNATIONAL A/S 50012 19F0301

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R PHARMACOLOGICAL TREATMENT FOR OVERACTIVE BLADDER