BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC FOLYSIL CATHETER 1.5ML CH06/5

    MDR report key: 1914748 · Received December 3, 2010

    Report

    Report Number
    9610711-2010-00003
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Report Date
    October 21, 2010
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K013174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. 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. DEVICE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDIATRIC FOLYSIL CATHETER 1.5ML CH06/5 SILICONE FOLEY CATHETER EZL COLOPLAST A/S AA61061002 9010226

    Patients

    Seq Age Sex Outcome Treatment
    1