BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURE CATHETER

    MDR report key: 6888544 · Received September 22, 2017

    Report

    Report Number
    3005471919-2017-00003
    Event Type
    Malfunction
    Date Received
    September 22, 2017
    Date of Event
    August 24, 2017
    Report Date
    September 22, 2017
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    EZD
    UDI-DI
    00815947020222
    PMA / PMN Number
    K072539
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE DID NOT OCCUR DURING INITIAL USE. FAILURE OCCURED AFTER EXTENDED USE. DEVICE IS CLEARED FOR INTERMITTENT BLADDER DRAINAGE, BUT WAS BEING USED FOR CONTINUOUS DRAINAGE WHILE BEING CONTINUOUSLY ATTACHED TO UROSTOMY BAG (CHANGED USUALLY 1-2 TIMES PER WEEK BUT SOMETIMES LESS FREQUENTLY). THE OFF-LABEL USAGE MAY HAVE CAUSED OR CONTRIBUTED TO DEVICE FAILURE DUE TO THE POTENTIAL FOR APPLICATION OF FORCE MAGNITUDES OR MODES BEYOND THE INTENDED USE. RESERVE AND RETURNED UNUSED SAME-LOT DEVICES WERE EVALUATED AND FOUND TO MEET SPECIFICATIONS. MANUFACTURING AND QUALITY CONTROL RECORDS DID NOT REVEAL ANY ISSUES WITH THE LOT. ACTUAL DEVICE WAS NOT RETURNED SO ROOT CAUSE CANNOT BE DETERMINED. NO OTHER SIMILAR REPORTS RECEIVED.

    Description of Event or Problem · 1

    WHILE USING INTERMITTENT CATHETER OFF-LABEL AS AN INDWELLING CATHETER FOR STOMA USE, THE FUNNEL SEPARATED AND THE TUBING WAS TEMPORARILY RETAINED IN THE PATIENT'S STOMA. THE TUBING WAS REMOVED IN THE HOSPITAL. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666578 CURE CATHETER URINARY CATHETER EZD CURE MEDICAL LLC F16 161112-4 00815947020222

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention