BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFLEX 29MM

    MDR report key: 2240752 · Received September 2, 2011

    Report

    Report Number
    MW5022125
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    September 2, 2011
    Manufacturer
    ROCHESTER MEDICAL CORPORATION
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE CATHETER IS REQUIRED FOR AN IMMOBILE FAMILY MEMBER. THE PROBLEM WITH THE ITEMS IS THE ADHESIVE THAT HOLDS THE CATHETER ON TO THE TUBE THAT GOES TO THE DISPOSAL CONTAINER DOES NOT HOLD. THE ADHESIVE IS NOT STRONG ENOUGH. IT HAS BECOME INFERIOR AS WE HAVE BEEN USING THESE CATHETERS FOR A WHILE NOW AND THE GLUE HAS SLOWLY BECOME CHEAPER AND FOR LACK OF BETTER WORDS, "SPRINGS LEAKS" OFTEN. MANUFACTURER HAS BEEN CONTACTED BUT, NO RESOLUTION WAS EVER MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIFLEX 29MM CATHETER KOD ROCHESTER MEDICAL CORPORATION 53418355

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR