BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.8% SURGISCREEN

    MDR report key: 1741794 · Received June 30, 2010

    Report

    Report Number
    2250051-2010-00162
    Event Type
    Injury
    Date Received
    June 30, 2010
    Date of Event
    June 28, 2010
    Report Date
    June 30, 2010
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INVESTIGATION PERFORMED BY OCD. CUSTOMER STATED THAT THE VIALS BROKE DUE TO USER DROPPING THEM. THERE WAS NO INDICATION OF A MALFUNCTION WITH THE VIALS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED CUTTING A FINGER WHILE CLEANING UP BROKEN GLASS FROM A VIAL OF 0.8% SURIGSCREEN. CUSTOMER INADVERTENTLY DROPPED TWO OF THE VIALS OF PRODUCT ON THE FLOOR. CUSTOMER INDICATES THAT HER RIGHT PINKY FIGURE HAD GOTTEN A SMALL LACERATION THROUGH GLOVES WHILE PICKING UP THE BROKEN GLASS WITH HER HANDS. CUSTOMER REPORTS THAT SHE WAS TREATED IN THE EMPLOYEE HEALTH DEPARTMENT WHO TREATED THE EVENT AS A MINOR CUT ACCIDENT AND NOT DEEMED OR TREATED AS AN EXPOSURE EVENT. OCD'S MEDICAL DIRECTOR HAS ASSESSED THIS AS A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SURGISCREEN REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VSS311

    Patients

    Seq Age Sex Outcome Treatment
    1 Other