BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.8 PERCENT SURGISCREEN

    MDR report key: 1456790 · Received August 14, 2009

    Report

    Report Number
    2250051-2009-00248
    Event Type
    Injury
    Date Received
    August 14, 2009
    Date of Event
    July 27, 2009
    Report Date
    August 14, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BROKEN VIAL WAS DISCARDED BY USER. TREATMENT WAS SOUGHT IMMEDIATELY IN THE HOSPITAL ER DEPARTMENT AS PER THEIR PROTOCOL. THE WOUND WAS CLEANED AND DRESSED WITH A BANDAID.

    Description of Event or Problem · 1

    USER OBTAINED A CUT ON THUMB WHILE OPENING A VIAL OF VSS247 CELL 1. THE WOUND BLED, BUT WAS NOT DEEP. TREATMENT WAS SOUGHT IMMEDIATELY IN THE HOSPITAL ER DEPARTMENT AS PER THEIR PROTOCOL. THE WOUND WAS CLEANED AND DRESSED WITH A BANDAID. OCD MEDICAL HAS ASSESSED THIS AS A SERIOUS INJURY. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8 PERCENT SURGISCREEN REAGENT RED BLOOD CELLS MWN ORTHO-CLINICAL DIAGNOSTICS VRA126

    Patients

    Seq Age Sex Outcome Treatment
    1