BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE BASIN SET

    MDR report key: 5789666 · Received July 13, 2016

    Report

    Report Number
    5789666
    Event Type
    Malfunction
    Date Received
    July 13, 2016
    Date of Event
    July 6, 2016
    Report Date
    July 8, 2016
    Manufacturer
    SYNERGY HEALTH AST, LLC
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OUR SYNERGY HEALTH SINGLE BASIN SET HAD A HOLE IN THE OUTER WRAP. THE BASIN WAS TAKEN OFF THE FIELD AND REPLACE WITH A NEW ONE AND A STERILE FIELD WAS ESTABLISHED BEFORE PATIENT ENTERED THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446650 SINGLE BASIN SET DRAPE, SURGICAL KKX SYNERGY HEALTH AST, LLC 5430E 16182

    Patients

    Seq Age Sex Outcome Treatment
    1