BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM SELF CATH FEMALE CH14

    MDR report key: 1833732 · Received September 14, 2010

    Report

    Report Number
    3005945907-2010-00022
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Report Date
    August 16, 2010
    Manufacturer
    COLOPLAST A/S
    Product Code
    KOD
    PMA / PMN Number
    K100878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT AVAILABLE TO BE RETURNED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (B)(4). ACCORDING TO THE INFORMATION RECEIVED, A CATHETER HAD A ROUGH TIP. THE USER REPORTED THAT THE CATHETER WAS NOT FORMED PROPERLY AT THE END. THE CATHETER WAS FLATTENED AND QUITE SHARP. THE ROUNDED END WAS NOT THERE AND IT IS SHORTER THAN THE USUAL CATHETER. CUSTOMER HAS CHECKED ALL OTHER CATHETERS AND THEY DO NO HAVE A FAULT ON THEM. CUSTOMER REALIZED THAT HOLES WERE AT THE TOP END SO IT APPEARS AS IF THE CATHETER HAS BEEN ASSEMBLED INCORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF CATH FEMALE CH14 INTERMITTENT CATHETER KOD COLOPLAST A/S 5046301020 2162289

    Patients

    Seq Age Sex Outcome Treatment
    1