BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGE CHEMO PLUS POWDERFREE

    MDR report key: 285458 · Received July 10, 2000

    Report

    Report Number
    MW1019265
    Event Type
    Injury
    Date Received
    July 10, 2000
    Date of Event
    July 10, 2000
    Report Date
    July 10, 2000
    Manufacturer
    SAGE PRODUCTS INC.
    Product Code
    LYY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    OPENED BOX OF CHEMO PLUS POWDERED LATEX EXAM GLOVES AND GOT READY TO MIX CYTOX AND INJECTION. THE FINGERS OF THE GLOVES ARE OPEN AND FULL OF HOLES. THESE ARE SUPPOSED TO PROTECT FROM CHEMOTHERAPY DRUG EXPOSURE. FALSE SECURITY, BAD BATCH, FAULTY PRODUCT. CALLED SAGE PRODUCTS AND WAS TOLD TO CALL KENDALL CO AND WAS TOLD HAD NO WAY TO TAKE A PRODUCT PROBLEM COMPLAINT. TOLD RPTR TO CALL SUPPLIER FOR A CREDIT AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGE CHEMO PLUS POWDERFREE LATEX EXAM GLOVES LYY SAGE PRODUCTS INC. * 809684185

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention