BEUDAMED
    FDA Adverse Event Summary report: N

    PROTEGRITY MCIRO SMT

    MDR report key: 1463500 · Received August 24, 2009

    Report

    Report Number
    1463500
    Date Received
    August 24, 2009
    Date of Event
    August 20, 2009
    Report Date
    August 24, 2009
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KGO
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    PROTEGIRTY MICRO SMT STERILE GLOVES PACKAGING IS CONFUSING TO STAFF. MANY STAFF MEMBERS INCLUDING STOCK ROOM STAFF HAVE MISINTERPRETED THE PACKAGING TO BE LATEX FREE GLOVES. THE PACKAGE STATES, "STERILE LATEX POWDER-FREE". WE HAVE FOUND THESE GLOVES ON LATEX FREE CARTS SEVERAL TIMES AND HAVE TRACKED IT DOWN TO THE PACKAGING. ALTHOUGH IT DOES HAVE A SYMBOL ON THE PACKAGE FOR LATEX, THE STAFF SEEMS TO OVERLOOK THIS AND LOOK AT THE "POWDER-FREE LATEX SURGICAL GLOVES WITH SYNTHETIC COATING" IN THE HEADING STATEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGRITY MCIRO SMT STERILE GLOVES KGO CARDINAL HEALTH * 11 TS08110322

    Patients

    Seq Age Sex Outcome Treatment
    1 *