BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURE CATHETER

    MDR report key: 5167709 · Received October 22, 2015

    Report

    Report Number
    3006430057-2015-00004
    Event Type
    Malfunction
    Date Received
    October 22, 2015
    Date of Event
    September 22, 2015
    Report Date
    October 21, 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

    (B)(4). 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 OF THE CUT COULD NOT BE DETERMINED. 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. THIS DOCUMENT REPRESENTS OUR INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    PATIENT'S SPOUSE REPORTED, "MY HUSBAND HAS USED YOUR 14F COUDE CATHETERS FOR OVER A YEAR, AND HAS BEEN VERY PLEASED WITH THEM. BUT HE ENCOUNTERED A PROBLEM YESTERDAY THAT YOU SHOULD BE AWARE OF. AFTER HE INSERTED A CATHETER, HE FELT A PAINFUL SCRATCHING, AND AFTER HE FINISHED AND REMOVED THE CATHETER, HE NOTICED A SHARP BARB ATTACHED TO THE TOP." PATIENT'S SPOUSE REPORTED THAT THERE WERE NO COMPLICATIONS, AND NO MEDICAL ATTENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699298 CURE CATHETER UROLOGICAL CATHETER EZD CURE MEDICAL LLC M14C 150327-4

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR