BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M3 MINI CATHETER

    MDR report key: 8050794 · Received November 7, 2018

    Report

    Report Number
    MW5081149
    Event Type
    Injury
    Date Received
    November 7, 2018
    Date of Event
    March 15, 2018
    Report Date
    October 12, 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

    USADE. SEEN BY NEPHROLOGIST FOR EVALUATION OF URINARY OBSTRUCTION, RENAL FAILURE, ELEVATED CREATININE AND BUN. KIDNEY ULTRASOUND PERFORMED (B)(6) 2018 REVEALED REGULAR WALL THICKENING AND MARKED PELVICALYCEAL DILATION RELATED TO BOTH KIDNEYS. REVIEW OF MEDICAL RECORD FOUND THAT THE PATIENT REFUSED TO HAVE THE CATHETER REMOVED. PATIENT HAD HIS M3 CATHETER IN PLACE FOR 148 DAYS. THE PATIENT HAD HIS M3 CATHETER REMOVED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885546 M3 MINI CATHETER UROLOGICAL CATHETER KOD MEDICAL INNOVATION LABS, LLC M3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other