BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2020394-1999-00010

    MDR report key: 261421 · Received November 24, 1999

    Report

    Report Number
    2020394-1999-00010
    Event Type
    Injury
    Date Received
    November 24, 1999
    Date of Event
    May 28, 1999
    Report Date
    October 25, 1999
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A CIRCULATING NURSE IN THE O.R. WAS NOT FAMILIAR WITH HOW TO OPEN THE INTERGARD GRAFT PACKAGING. NURSE TORE OPEN THE FOIL POUCH AND PUT THE OUTER NON-STERILE TRAY ON THE STERILE FIELD. THE DOUBLE TRAY WAS OPENED BY THE SCRUB NURSE AND THE GRAFT WAS IMPLANTED. SUBSEQUENTLY, THE PT DEVELOPED A GRAFT INFECTION AND THE GRAFT WAS EXPLANTED. THE NURSE STATED THAT THE LABELING WAS CONFUSING AND LETTERING WAS TOO SMALL.

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention