BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONVEEN SPEEDICATH

    MDR report key: 609834 · Received May 31, 2005

    Report

    Report Number
    9610694-2005-00001
    Event Type
    Other
    Date Received
    May 31, 2005
    Date of Event
    May 3, 2005
    Report Date
    May 23, 2005
    Manufacturer
    COLOPLAST A/S
    Product Code
    KDD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN MAY CO RECEIVED A CUSTOMER COMPLAINT CALL TO THE CUSTOMER SERVICE GROUP STATING THAT CUSTOMER HAD USED A SPEEDICATH MALE CH 14 CATHETER ABOUT TWO WEEKS EARLIER. CUSTOMER FELT DISCOMFORT AND NOTICED BLEEDING THEN LATER IN THE DAY BECAME QUEASY AND LIGHT-HEADED. CUSTOMER CALLED 911 AND WAS ADMITTED THROUGH ER TO THE HOSPITAL. CUSTOMER WAS HOSPITALIZED FOR 6 DAYS DUE TO A RUPTURED SPHINCTER CAUSING SEPTIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVEEN SPEEDICATH INTERMITTENT CATHETER KDD COLOPLAST A/S * 290690

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization