BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M3 MINI CATHETER

    MDR report key: 8050793 · Received November 7, 2018

    Report

    Report Number
    MW5081148
    Event Type
    Injury
    Date Received
    November 7, 2018
    Date of Event
    December 17, 2017
    Report Date
    October 15, 2018
    Manufacturer
    MEDICAL INNOVATION LABS, LLC
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HOSPITALIZED WITH URINARY RETENTION, BLADDER OUTLET OBSTRUCTION AND ACUTE RENAL FAILURE. CREATININE LEVEL 9.5 MG/DL ON ADMISSION. THE PATIENT WAS SEEN BY UROLOGY AND NEPHROLOGY. WHEN PATIENT WAS IN THE EMERGENCY ROOM, THE M3 MINI CATHETER WAS CUT AND LEFT IN PLACE AND A FOLEY CATHETER WAS INSERTED. THE PATIENT VOIDED 1300CC OF URINE. THE SAME M3 MINI CATHETER WAS IN PLACE FOR 57 DAYS. AT DISCHARGE THE CREATININE LEVEL WAS 3.8 MG/DL. DESIGN FLAW WITH ¿TOP HEAVY¿ IN SOME PATIENTS PROMOTES MIGRATION BACK INTO BLADDER. PT HAD NEW DEVICE PLACED AND SUBSEQUENTLY HAD A TURP. RENAL FUNCTION CURRENTLY CREATININE 1.9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885545 M3 MINI CATHETER UROLOGICAL CATHETER KOD MEDICAL INNOVATION LABS, LLC M3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization