BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE CATHETER HYDROPHILIC COATED

    MDR report key: 8941027 · Received August 28, 2019

    Report

    Report Number
    3005471919-2019-00064
    Event Type
    Injury
    Date Received
    August 28, 2019
    Date of Event
    July 22, 2019
    Report Date
    August 28, 2019
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    EZD
    PMA / PMN Number
    K132500
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) REPORTED DIFFICULTY INSERTING CATHETER ACCORDING TO MANUFACTURER'S RECOMMENDATIONS AND RECOGNIZED BEST PRACTICES. THE RECOMMENDED INSERTION METHOD INVOLVES HYDRATING THE HYDROPHILIC COATING ON THE CATHETER PRIOR TO INSERTION BY BURSTING A WATER PACKET CONTAINED WITHIN THE DEVICE PACKAGING. DUE TO INITIAL INSERTION DIFFICULTY THE PATIENT DECIDED TO DISCONTINUE LUBRICATING THE CATHETER WITH THE INCLUDED WATER PACKET AND BEGAN APPLYING HIS OWN KY JELLY TO CATHETER. THIS IS NOT AN APPROVED LUBRICATION METHOD FOR THE HYDROPHILIC CATHETER AND PROVIDES AN UNKNOWN LEVEL OF LUBRICITY. THE PATIENT REPORTED THAT OVER A PERIOD OF AT LEAST 6 MONTHS OF USING THE UNRECOGNIZED INSERTION METHOD HE EXPERIENCED BITS OF BLOOD CLOTS AND BLOOD IN HIS URINE. ULTIMATELY HE WAS ADMITTED TO THE HOSPITAL TO HAVE A SUPER PUBIC CATHETER INSERTED TO DRAIN HIS BLADDER DUE TO EXCESSIVE BLEEDING EXPERIENCED DURING SELF-CATHETERIZATION. PATIENT REPORTED HE IS NOW DOING FINE DRAINING HIS BLADDER WITH THE SUPER PUBIC CATHETER AND IS STILL BEING EVALUATED TO DETERMINE IF HE WILL RETURN TO INTERMITTENT SELF-CATHETERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733318 CURE CATHETER HYDROPHILIC COATED URINARY CATHETER EZD CURE MEDICAL LLC HM14

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| O