BEUDAMED
    FDA Adverse Event Summary report: N

    CENTURION

    MDR report key: 7013388 · Received November 9, 2017

    Report

    Report Number
    MW5073183
    Date Received
    November 9, 2017
    Date of Event
    October 30, 2017
    Report Date
    November 7, 2017
    Manufacturer
    CENTURION
    Product Code
    KMK
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STAGE II HAPU FOUND UNDER PIV. THE CENTURION DRESSING IS A 2-PIECE DESIGN INTENDED TO KEEP IV LINES MORE SECURELY IN PLACE. IT WAS NOTED THE 2ND PIECE OF THE DRESSING LAYS DIRECTLY OVER THE IV HUB, APPEARING TO CAUSE ADD'L PRESSURE AT THE HUB SITE. ADDITIONALLY, THE CENTURION DRESSING IS NOT TRANSPARENT WHICH MAKES VISUALIZATION OF THE UNDERLYING SKIN DIFFICULT IN BETWEEN DRESSING CHANGES. DURING SIMULATION, THE INDENT OF THE IV HUB ON A HEALTHY INDIVIDUAL'S ARM WAS ALREADY VISIBLE AFTER ONLY 10 MINUTES OF DRESSING APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794290 CENTURION SORBAVIEW SHIELD PIV DRESSING KMK CENTURION SV233UDT

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR