BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNAP

    MDR report key: 11991159 · Received June 14, 2021

    Report

    Report Number
    11991159
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 19, 2021
    Report Date
    May 24, 2021
    Manufacturer
    KCI USA, INC.
    Product Code
    OKO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6): SNAP THERAPY SYSTEM DRESSING 15 X 15 CM WAS RECEIVED WITH DISCOLORED FOAM. FOAM IS BLUE, BY STANDARD, BUT APPEARED TO HAVE A GREEN EDGE. ALL PACKAGES WITHIN THE RECENT SHIPMENT CONTAINED FOAM THAT WAS DISCOLORED GREEN ALONG THE EDGE. ALL 10 BOXES OF PRODUCT WERE INSPECTED AND DISCOVERED TO HAVE SIMILAR DEFECT. PRODUCT WAS NOT APPLIED TO THE PATIENT. PRODUCT REP WAS CONTACTED ABOUT DEFECTIVE CONCERNS. PRODUCT IS BEING REPLACED AT NO CHARGE, WITH PRODUCT RETURNED TO DISTRIBUTOR/MANUFACTURER THROUGH PRODUCT REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891652 SNAP NEGATIVE PRESSURE WOUND THERAPY NON-POWERED SUCTION APPARATUS OKO KCI USA, INC. 8477883V002

    Patients

    Seq Age Sex Outcome Treatment
    1