BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEROWET SUPERSHIELD

    MDR report key: 3888144 · Received June 2, 2014

    Report

    Report Number
    3888144
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    June 28, 2013
    Report Date
    June 2, 2014
    Manufacturer
    ZEROWET, INC.
    Product Code
    KYZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321834 ZEROWET SUPERSHIELD WOUND, IRRIGATING DEVICE KYZ ZEROWET, INC. * S13-01

    Patients

    Seq Age Sex Outcome Treatment
    1 *