BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-TRAK (LARGE) ANCHORING DEVICE 50PACK

    MDR report key: 6123255 · Received November 22, 2016

    Report

    Report Number
    1000317571-2016-00094
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 24, 2016
    Report Date
    October 24, 2016
    Manufacturer
    CONVATEC LIMITED
    Product Code
    KGZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION AND A NON-SERIOUS INJURY. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT NOT PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON NOVEMBER 22, 2016.

    Description of Event or Problem · 1

    COMPLAINT REPORTED, "CATHETER INSERTED, FLEXI-TRACK ATTACHED, PATIENT SHOWERED THE NEXT DAY, NURSE FINDS FLEXI-TRACK FLAPS/TABS HAVE DETACHED AND CATHETER IS NO LONGER ATTACHED CAUSING TRAUMA FOR THE BLADDER NECK, URETHRA AND DISCOMFORT FOR THE PATIENT. AT TIMES THERE WILL ALSO BE BLEEDING FROM TRAUMA AT CATHETER SITE." THE REPORTER CLARIFIED THAT THERE WAS "NO HEMORRHAGE BUT BLOOD AROUND SITE CAUSED THROUGH THE TRAUMA OF THE DETACHMENT" NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774060 FLEXI-TRAK (LARGE) ANCHORING DEVICE 50PACK ACCESSORIES, CATHETER KGZ CONVATEC LIMITED 37449

    Patients

    Seq Age Sex Outcome Treatment
    1