BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LA1 SCREENING REAGENT/LA2 CONFIRMATION REAGENT

    MDR report key: 627959 · Received July 26, 2005

    Report

    Report Number
    9610806-2005-00015
    Event Type
    Malfunction
    Date Received
    July 26, 2005
    Date of Event
    June 22, 2005
    Report Date
    July 19, 2005
    Manufacturer
    DADE BEHRING GMBH
    Product Code
    GIR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LABORATORIAN RECEIVED A LACERATION WHILE ATTEMPTING TO OPEN A VIAL OF LA2 REAGENT. THE VIAL BROKE AS THE LABORATORIAN WAS REMOVING THE CAP FROM THE VIAL. LABORATORIAN RECEIVED MEDICAL TREATMENT FOR THE LACERATION, PLASTIC STITCHES AND A TETANUS SHOT AT THE EMERGENCY ROOM. UPON INSPECTION, THE LABORATORIAN NOTICED SHARDS OF GLASS IN THE BOTTOM OF THE SHIPPING CONTAINER. THE VIAL BREAKAGE MOST LIKELY OCCURRED DURING TRANSIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LA1 SCREENING REAGENT/LA2 CONFIRMATION REAGENT SIMPLIFIED DILUTE RUSSELL'S VIPER VENOM TEST GIR DADE BEHRING GMBH NA 524209

    Patients

    Seq Age Sex Outcome Treatment
    1 *