BEUDAMED
    FDA Adverse Event Summary report: N

    ESSENTIALS

    MDR report key: 1676148 · Received May 4, 2010

    Report

    Report Number
    1676148
    Date Received
    May 4, 2010
    Date of Event
    May 4, 2010
    Report Date
    May 4, 2010
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    LRP
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GENZYME BIOSURGERY ESSENTIALS KIT ITEM # 82004.A CLEAR PLASTIC PACKAGE IS CONTAINED WITHIN AN OUTER CARDBOARD BOX. THE OUTER BOX IS OBVIOUSLY NOT STERILE. THE INNER CLEAR PLASTIC (SEALED PACKAGE) LABEL STATES "CAUTION: NON STERILE PACKAGING" THEN LISTS THE CONTENTS FOLLOWED BY "STERILE CONTENTS UNLESS INDIVIDUAL PACKAGES HAVE BEEN OPENED OR DAMAGED".THE PACKAGE WAS OPENED USING STERILE TECHNIQUE AND THE CONTENTS DUMPED ONTO THE STERILE FIELD. THE INNER COMPARTMENTS WERE OPENED AND USED IN SURGERY. AFTER SURGERY WAS COMPLETED, IT WAS IDENTIFIED THAT THE INNER CONTENT "PACKAGES" ARE NOT STERILE - THEREFORE THE STERILE FIELD WAS INADVERTENTLY CONTAMINATED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================A BREACH IN OPERATIVE STERILITY EXPOSES THE PATIENT TO RISK OF INFECTION. PT IS BEING TREATED WITH PROPHYLACTIC ANTIBIOTICS; OUTCOME WILL NOT BE CLEAR FOR SOME TIME.====================== MANUFACTURER RESPONSE FOR GENZYME BIOSURGERY ESSENTIALS KIT ======================SALES REP WAS PRESENT FOR THIS SURGERY BUT DID NOT IDENTIFY THE MISTAKE WHEN IT WAS MADE. REP EXPLAINED GENZYME IS AWARE OF AT LEAST ONE OTHER SIMILAR EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSENTIALS SURGICAL KIT LRP GENZYME BIOSURGERY * RM00781

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR