BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOME SELF CATH PLUS MALE CH08

    MDR report key: 3230203 · Received July 16, 2013

    Report

    Report Number
    3005945907-2013-00004
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    June 12, 2013
    Manufacturer
    COLOPLAST A/S
    Product Code
    KOD
    PMA / PMN Number
    K003784
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND IT WAS VISUALLY VERIFIED THAT THE DEVICE WAS MISSING EYELETS ON THE TIP OF THE CATHETER. BASED UPON EXAMINATION OF THE RETURNED PRODUCT THIS COMPLAINT CAN BE CONFIRMED AS REPORTED.

    Description of Event or Problem · 1

    PATIENT IDENTIFIER: (B)(6). DATE OF EVENT: BEST ESTIMATE (B)(6) 2013. ACCORDING TO THE INFORMATION RECEIVED AN END USER TRYING CATHING WITH A CATHETER WITHOUT ANY EYELETS. HE WAS AT A RESTAURANT AND THEREFORE COULD NOT EMPTY HIS BLADDER FOR SEVERAL MORE HOURS (UNTIL HE RETURNED HOME). UPON RETURNING HOME HE FOUND ANOTHER CATHETER THAT WAS THE SAME WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328581 FREEDOME SELF CATH PLUS MALE CH08 INTERMITTENT CATHETER KOD COLOPLAST A/S 5049001400 1889962

    Patients

    Seq Age Sex Outcome Treatment
    1 Other