BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM SELF-CATH NELATON CH12

    MDR report key: 1595930 · Received February 9, 2010

    Report

    Report Number
    2183558-2010-00003
    Event Type
    Injury
    Date Received
    February 9, 2010
    Report Date
    January 12, 2010
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    EYB
    PMA / PMN Number
    K003784
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THE TIP OF THE CATHETERS HAD BEEN CAUGHT IN THE SEAL OF THE POUCH AND CUT OFF DURING PACKAGING. THIS WAS EVIDENCED BY THE VOID IN THE SEAL; THEREFORE, THE COMPLAINT IS CONFIRMED AS REPORTED.

    Description of Event or Problem · 1

    (B) (6). DATE OF EVENT IS (B) (6) /2010.ACCORDING TO THE INFORMATION RECEIVED, AN END USER REPORTED A CUTOFF CATHETER. THE CUSTOMER STATED THAT THE TIP OF THE CATHETER WAS CUT OFF, FORMING A SHARP POINT AND CAUSING BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF-CATH NELATON CH12 INTERMITTENT CATHETER EYB COLOPLAST MANUFACTURING US, LLC 5045201400 2013457

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention