BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGIC HYDROPHILIC-COATED FEMALE INTERMITTENT CATHETER 14 FR

    MDR report key: 4935906 · Received July 19, 2015

    Report

    Report Number
    MW5044651
    Event Type
    Injury
    Date Received
    July 19, 2015
    Date of Event
    June 25, 2015
    Report Date
    July 19, 2015
    Manufacturer
    BARD MEDICAL
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USED DEFECTIVE MAGIC HYDROPHILIC-COATED FEMALE INTERMITTENT CATHETER 14 FR ACQUIRED FROM BARD MEDICAL DIVISION. BARD RECALLED UNUSED CATHETERS BECAUSE OF A VOID IN THE PACKAGE SEAL WHICH COULD CAUSE PRODUCT TO BE UNSTERILE. I USED THE PRODUCT PRIOR TO THE COMPANY'S NOTIFICATION AND GOT A SEVERE URINARY TRACT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467963 MAGIC HYDROPHILIC-COATED FEMALE INTERMITTENT CATHETER 14 FR MAGIC HYDROPHILIC-COATED FEMALE INTERMITTENT CATHETER 14 FR KOD BARD MEDICAL 73600124

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other