BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM SELF-CATH NELATON CH14

    MDR report key: 2210137 · Received August 12, 2011

    Report

    Report Number
    3005945907-2011-00016
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Report Date
    July 15, 2011
    Manufacturer
    COLOPLAST A/S
    Product Code
    KOD
    PMA / PMN Number
    K100878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 OCCURRENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    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 OCCURRENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED. FOLLOW UP 1: 180 PCS WERE RECEIVED FOR EVALUATION. BOX WAS LABELED "ITEM: 5045301400, LOT # 2575557, BUT INSIDE THE PRODUCTS WERE "ITEM: 5047401400, LOT # 2592719". THIS COMPLAINT WAS CONFIRMED AS REPORTED.

    Description of Event or Problem · 1

    (B)(6). DATE OF EVENT: BEST ESTIMATE IS (B)(6) 2011. ACCORDING TO THE INFORMATION RECEIVED THE USER STATED THAT A BOX OF CATHETERS WAS LABELED 414 BUT GOT 814 CATHETERS INSIDE.

    Description of Event or Problem · 1

    (B)(4).ACCORDING TO THE INFORMATION RECEIVED THE USER STATED THAT A BOX OF CATHETERS WAS LABELED 414 BUT GOT 814 CATHETERS INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF-CATH NELATON CH14 INTERMITTENT CATHETER KOD COLOPLAST A/S 5045301400 2575557

    Patients

    Seq Age Sex Outcome Treatment
    1