BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAPE, BASIN PACK

    MDR report key: 7288581 · Received February 22, 2018

    Report

    Report Number
    7288581
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    February 1, 2018
    Report Date
    February 12, 2018
    Manufacturer
    NOVO HEALTH SERVICES
    Product Code
    KGT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS I WAS OPENING FOR A TOTAL KNEE, THE DRAPE FOR THE DOUBLE BASIN HAD A HOLE IN IT. I HAD ALREADY PUT IT ON THE TABLE WHEN WE FOUND IT, BUT IT WASN'T TOUCHING ANYTHING. WE REMOVED IT BEFORE CONTINUING. WE OPENED AN IOBAN TO COVER THE CONTAMINATED AREA AND MADE SURE NOTHING WAS PUT IN THAT AREA. ONCE I SCRUBBED IN, I COVERED THE CONTAMINATED AREA WITH THE IOBAN AND CHANGED MY GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134204 DRAPE, BASIN PACK KGT NOVO HEALTH SERVICES 127566A

    Patients

    Seq Age Sex Outcome Treatment
    1