BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXSYM CARBAMAZEPINE CONTROLS

    MDR report key: 53072 · Received November 27, 1996

    Report

    Report Number
    2623532-1996-00014
    Event Type
    Other
    Date Received
    November 27, 1996
    Date of Event
    October 29, 1996
    Report Date
    November 27, 1996
    Manufacturer
    ABBOTT HEALTH PRODUCT, INC.
    Product Code
    KLT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    ON 10/29/96, A LAB TECH AT THE ACCOUNT SPLASHED CARBAMAZEPINE CONTROL REAGENT INTO HER EYES, WHILE ATTEMPTING TO DISPENSE THE LOW CONTROL INTO A SAMPLE CUP. THE NOZZLE TIP OF THE LOW CONTROL VIAL APPEARED TO BE PLUGGED, BECAUSE LIQUID WAS NOT EXPELLED WHEN THE VIAL WAS PRESSED. THE TECH WAS REMOVING THE NOZZLE TIP, TO ENABLE MANUAL PIPETTING OF THE CONTROL, WHEN THE CONTROL REAGENT SPLASHED INTO HER EYES. THE TECH DABBED HER EYES, BUT SHE DID NOT FLUSH AT THE EYEWASH STATION, NOR SEEK MEDICAL ATTENTION. THE CUSTOMER CALLED TO INQUIRE IF CO CONTROL REAGENTS ARE TESTED FOR INFECTIOUS MATERIAL. SHE WAS ADVISED, PER THE PACKAGE INSERT, TO NOTE THE SAFETY PRECAUTIONS SECTION AND TO FOLLOW LAB BIOHAZARD EXPOSURE POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM CARBAMAZEPINE CONTROLS CARBAMAZEPINE PREPARED CONTROLS KLT ABBOTT HEALTH PRODUCT, INC. NA 12550Q100

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other