BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.8% SURGISCREEN

    MDR report key: 2122182 · Received June 13, 2011

    Report

    Report Number
    2250051-2011-00139
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCD MEDICAL HAS ASSESSED THIS AND DETERMINED THIS TO BE A SERIOUS INJURY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A LAB OPERATOR CUT HER FINGER WITH A BROKEN REAGENT RED BLOOD CELL VIAL WHILE UNPACKING A REAGENT DELIVERY. THE CUSTOMER SAID THE LAB OPERATOR WAS NOT WEARING PROTECTING GLOVES. THE CUT WAS A SUPERFICIAL WOUND. THE LAB OPERATOR WASHED HER FINGER, RINSED IT WITH A DISINFECTANT, AND PUT A BAND-AID ON THE CUT. OPERATOR DID NOT RECEIVE ANY MEDICATION AND DID NOT REQUIRE ANY SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SURGISCREEN REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS 8SS691

    Patients

    Seq Age Sex Outcome Treatment
    1 Other