BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM SELF CATH PLUS MALE CH10

    MDR report key: 1660019 · Received April 15, 2010

    Report

    Report Number
    2183558-2010-00010
    Event Type
    Malfunction
    Date Received
    April 15, 2010
    Date of Event
    March 21, 2010
    Report Date
    March 22, 2010
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    KOD
    PMA / PMN Number
    K003784
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED PRODUCT REVEALED ONE POUCH WAS EMPTY BUT COMPLETELY SEALED, ONE WAS A CUT-OFF AND THE OTHER THREE WERE FULLY INTACT WITHIN THEIR POUCHES. THEREFORE, THE COMPLAINT IS CONFIRMED AS REPORTED. CLOSER EXAMINATION OF THE CUT-OFF DID REVEAL A VOID IN THE SEAL, INDICATING THE CATHETER TIP WAS SEALED IN THE POUCH DURING THE PACKAGING PROCESS DURING MANUFACTURING. THE COMPLAINT HISTORY WAS REVIEWED, REVEALING THAT THIS IS THE FIRST SUCH COMPLAINT FOR THIS LOT NUMBER. BASED ON THIS INFORMATION, COLOPLAST CONCLUDES THAT THIS IS AN ISOLATED INCIDENT AND DOES NOT REPRESENT THE OVERALL QUALITY OF THE LOT.

    Description of Event or Problem · 1

    (B)(6). ACCORDING TO THE INFORMATION RECIEVED, A CATHETER HAD A TIP CUT OFF/OPEN/BROKEN. THE CUSTOMER STATED THAT 3 CATHETERS HAD CUT-OFF TIPS AND 2 HAD EMPTY SLEEVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF CATH PLUS MALE CH10 INTERMITTENT CATHETER KOD COLOPLAST MANUFACTURING US, LLC 5049101400 2051315

    Patients

    Seq Age Sex Outcome Treatment
    1