BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.8% RESOLVE PANEL A

    MDR report key: 846056 · Received May 2, 2007

    Report

    Report Number
    2250051-2007-70204
    Event Type
    Injury
    Date Received
    May 2, 2007
    Date of Event
    April 4, 2007
    Report Date
    May 2, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER DROPPED CELL #5 OF 0.8% RESOLVE PANEL A AND SHE CUT HERSELF IN THE PROCESS OF CLEANING UP THE BROKEN VIAL. THE CUSTOMER WASHED THE WOUND AND WENT TO THE ER. NO SUTURES WERE REQUIRED, CUSTOMER RETURNED TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% RESOLVE PANEL A REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS NA 8RA207

    Patients

    Seq Age Sex Outcome Treatment
    1 *