BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC NELATON CH10

    MDR report key: 3181404 · Received June 14, 2013

    Report

    Report Number
    3009632672-2013-00006
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    January 17, 2011
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    KOD
    PMA / PMN Number
    K896750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUBMISSION IS BEING MADE AFTER AN ACQUISITION AND INTERNAL AUDIT OF WELLSPECT HEALTHCARE. SOME OF THE CATHETERS ANALYZED HAD A DROP OF EXCESS COATING IN THE AREA OF THE COATED/UNCOATED CATHETER CLOSE TO THE CONNECTOR. NO OTHER COATING IRREGULARITIES WERE FOUND. BATCH DOCUMENTATION SHOWS NO ABNORMALITIES. A DROP OF EXCESS COATING IN THE AREA OF THE COATED/UNCOATED CATHETER, WHICH SOMETIMES CAN BE FORMED DURING THE COATING PROCESS, IS ACCEPTED IN THE QUALITY CONTROL SINCE THEY ARE USUALLY DISSOLVED DURING THE WETTING OF THE CATHETER.

    Description of Event or Problem · 1

    A PATIENT IS COMPLAINING ABOUT SOMETIMES HAVING A BLEEDING AFTER CATHETERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270662 LOFRIC NELATON CH10 CATHETER UROLOGICAL, KOD KOD WELLSPECT HEALTHCARE 9010 61740, 67463, 64985

    Patients

    Seq Age Sex Outcome Treatment
    1 Other