BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASIN

    MDR report key: 6182935 · Received December 16, 2016

    Report

    Report Number
    0001527607-2016-00001
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 17, 2016
    Report Date
    December 16, 2016
    Manufacturer
    SYNERGY HEALTH NORTH AMERICA
    Product Code
    FNY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVEN THOUGH THERE WERE NO REPORTED ADVERSE EVENTS, THE MEDWATCH REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THERE APPEARED TO BE A BLUE SUBSTANCE AND RED SPOTS ON THE STAINLESS BASIN THAT IS USED FOR SOLUTIONS IN THE OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833456 BASIN FNY SYNERGY HEALTH NORTH AMERICA 121716 538562001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other