BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M3 MINI CATHETER

    MDR report key: 8050835 · Received November 7, 2018

    Report

    Report Number
    MW5081150
    Event Type
    Injury
    Date Received
    November 7, 2018
    Date of Event
    September 14, 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

    PRESENTED TO HOSP WITH SIGNS OF DEHYDRATION AND ACUTE RENAL FAILURE. PATIENT WAS EXPERIENCING URINARY RETENTION PROBLEMS. PATIENT SEEN BY UROLOGIST. PATIENT GIVEN IV FLUIDS FOR SUSPECTED UTI. CREATININE LEVEL WAS ELEVATED: 2.5 MG/DL. DISCHARGE CREATININE LEVEL 1.8 MG/DL. DEVICE MIGRATION DUE TO DESIGN FLAW. DEVICE ABILITY TO MIGRATE DUE TO ASYMMETRY OF DESIGN "TOP HEAVY¿ AND HAS TENDENCY IN SOME PROSTATES TO MIGRATE BACK INTO BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885530 M3 MINI CATHETER UROLOGICAL CATHETER KOD MEDICAL INNOVATION LABS, LLC M3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization