BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHEATON SCIENCE PRODUCTS

    MDR report key: 67635 · Received February 7, 1997

    Report

    Report Number
    1523845-1997-00001
    Event Type
    Malfunction
    Date Received
    February 7, 1997
    Date of Event
    February 2, 1997
    Report Date
    February 7, 1997
    Manufacturer
    WHEATON SCIENCE PRODUCTS
    Product Code
    KJC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ON 2/3/97, DISTRIBUTOR RECEIVED A REPORT INDICATING THAT A FIRE HAD OCCURRED. THE FIRE APPEARS TO HAVE ORIGINATED IN A TISSUE CULTURE CELL ROLLER LAB INCUBATOR. THE FIRE WAS CONTAINED BY, AND WITHIN, THE INCUBATOR. THERE WAS NO LOSS OF LIFE NOR INJURY, HOWEVER THERE WAS DAMAGE TO THE CELL ROLLER AND INCUBATOR, AND THERE WAS REPORTED LOSS OF PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHEATON SCIENCE PRODUCTS BOTTLE ROLLER, TISSUE CULTURE KJC WHEATON SCIENCE PRODUCTS 4862 (WHEATON NO 348942) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other