BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM SELF-CATH TIEMANN TAPERTIP CH14

    MDR report key: 1633725 · Received March 17, 2010

    Report

    Report Number
    3005945907-2010-00006
    Event Type
    Malfunction
    Date Received
    March 17, 2010
    Report Date
    February 3, 2010
    Manufacturer
    COLOPLAST A/S
    Product Code
    EYB
    PMA / PMN Number
    K003784
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    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). DATE OF EVENT: BEST ESTIMATE IS (B)(6) 2010. ACCORDING TO THE INFORMATION RECEIVED, A PHARMACY REPORTED A CATHETER WITH MISSING EYELETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF-CATH TIEMANN TAPERTIP CH14 INTERMITTENT CATHETER EYB COLOPLAST A/S 5046801400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1