BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PED 2WY LATEX CATHETER

    MDR report key: 148826 · Received February 13, 1998

    Report

    Report Number
    2183558-1998-00006
    Event Type
    Injury
    Date Received
    February 13, 1998
    Report Date
    January 16, 1998
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    KOD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER THE INFORMATION PROVIDED TO CO BY THE PATIENT, VIA CO'S INTERNATIONAL DISTRIBUTOR, A 16 FRENCH CATHER WAS IN A PACKAGE FOR A 14 FRENCH CATHETER. THE PATIENT REPORTS THAT BECAUSE OF THE SIZE DIFFERENCE, AS WELL AS "ROUGH EYELETS," THERE WAS BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PED 2WY LATEX CATHETER CATHETER KOD MENTOR UROLOGY, INC. NA 60805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention