BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUOLOCK TAIL CLSR CURVED TAN

    MDR report key: 5527133 · Received March 25, 2016

    Report

    Report Number
    1000317571-2016-00032
    Event Type
    Malfunction
    Date Received
    March 25, 2016
    Report Date
    March 2, 2016
    Manufacturer
    CONVATEC LIMITED
    Product Code
    EZS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE END USER THAT THE TAIL CLIPS DIG AND IRRITATE HER FLESH IN THE AREA OF THE ABDOMEN WHERE THE CLIP RESTS/DIGS IN. IT WAS ALSO REPORTED THAT THIS HAS OCCURRED WITH OTHER SIMILAR PRODUCTS FOR YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182174 DUOLOCK TAIL CLSR CURVED TAN APPLIANCE, COLOSTOMY, DISPOSABLE EZS CONVATEC LIMITED SRA8280

    Patients

    Seq Age Sex Outcome Treatment
    1