BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURE CATHETER

    MDR report key: 5259808 · Received December 1, 2015

    Report

    Report Number
    3005471919-2015-00004
    Event Type
    Malfunction
    Date Received
    December 1, 2015
    Date of Event
    September 22, 2015
    Report Date
    December 1, 2015
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    EZD
    PMA / PMN Number
    K072539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONLY THE TIP PORTION OF A 14 FRENCH COUDE CATHETER WAS RETURNED FOR EVALUATION. THE TIP HAD A SMALL CUT WITH A 1MM FLAP THAT WAS NOT PRONE TO DETACHING. THE PACKAGE WAS NOT RETURNED AND COULD NOT BE EVALUATED. THE ROOT CAUSE INVESTIGATION IS ONGOING. MANUFACTURER HAS REVIEWED THE DEVICE HISTORY RECORDS, QUALITY INSPECTION DATA, AND COMPLAINT HISTORY FOR THE DEVICE. A REVIEW OF THE FINAL INSPECTION REPORT AND DHR FOR THIS LOT INDICATE NO ANOMALIES THAT WOULD CONTRIBUTE TO THIS EVENT.

    Description of Event or Problem · 1

    USER'S SPOUSE REPORTED THAT USER FELT PAIN UPON CATHETERIZATION BUT THAT THERE WERE NO COMPLICATIONS AND NO MEDICAL ATTENTION WAS REQUIRED. USER RETURNED THE TIP PORTION OF THE USED 14F COUDE CATHETER. EVALUATION SHOWED A SMALL CUT AND A 1MM FLAP NEAR THE BEND OF THE COUDE TIP. THE FLAP WAS NOT PRONE TO DETACHING BUT MAY CAUSE DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788636 CURE CATHETER UROLOGICAL CATHETER EZD CURE MEDICAL LLC M14C 150327-4

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR