BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE ORTHOPAEDIC LATEX POWDER-FREE SURGICAL GLOVE

    MDR report key: 2061830 · Received April 8, 2011

    Report

    Report Number
    2061830
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 8, 2011
    Manufacturer
    ANSELL HEALTHCARE PRODUCTS LLC
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    A SURGEON WAS SCRUBBING FOR A SURGICAL CASE. HE PROCEEDED TO DRY HIS HANDS, PUT THE GOWN ON, AND THEN HE PUTS THE SURGICAL GLOVES ON. UPON PLACING HIS HANDS INTO THE GLOVES, SOMETHING SHARP, POKED HIS SKIN. IT DID NOT BREAK THE SKIN. HE REMOVED THE GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE ORTHOPAEDIC LATEX POWDER-FREE SURGICAL GLOVE TEXTURED SURGICAL GLOVES KGO ANSELL HEALTHCARE PRODUCTS LLC LATEX POWDER FREE 1005023205

    Patients

    Seq Age Sex Outcome Treatment
    1 *