BEUDAMED
    FDA Adverse Event Other Summary report: N

    VIROTROL HIV-2

    MDR report key: 3240820 · Received July 18, 2013

    Report

    Report Number
    2016706-2013-00001
    Event Type
    Other
    Date Received
    July 18, 2013
    Date of Event
    June 13, 2013
    Report Date
    July 17, 2013
    Manufacturer
    BIO-RAD LABS
    Product Code
    JJY
    PMA / PMN Number
    BK920028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABELING FOR VIROTROL HIV-2 INDICATES "EACH HUMAN DONOR UNIT USED IN THE PREPARATION OF THIS PRODUCT HAS BEEN TESTED USING LICENSED REAGENTS AND FOUND TO BE NON-REACTIVE FOR HEPATITIS B SURFACE ANTIGEN, ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUS (HIV) TYPE 1 AND ANTIBODIES TO HEPATITIS C VIRUS. HOWEVER, NO KNOWN TEST METHOD CAN ASSURE THAT PRODUCTS DERIVED FROM HUMAN SOURCES WILL NOT TRANSMIT INFECTION. IT IS RECOMMENDED THAT THIS PRODUCT AND ALL HUMAN SPECIMENS BE HANDLED IN ACCORDANCE WITH BIOSAFETY LEVEL 2 PRACTICES AS DESCRIBED IN THE UNITED STATES DEPT OF HEALTH AND HUMAN SVS CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) AND NATIONAL INSTITUTES OF HEALTH (NIH), BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABS, OR OTHER EQUIVALENT GUIDELINES.

    Description of Event or Problem · 1

    A HOSPITAL EMPLOYEE SPLASHED CONTROL MATERIAL ON HER CHEEK. THERE WAS NO IMMEDIATE HARM TO THE HOSPITAL EMPLOYEE AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335264 VIROTROL HIV-2 QUALITY CONTROL MATERIAL JJY BIO-RAD LABS NA B114630

    Patients

    Seq Age Sex Outcome Treatment
    1 Other