BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLEXAM

    MDR report key: 513573 · Received January 20, 2004

    Report

    Report Number
    9680651-2004-00001
    Event Type
    Other
    Date Received
    January 20, 2004
    Date of Event
    December 1, 2003
    Report Date
    January 7, 2004
    Manufacturer
    SEAL POLYMER INDUSTRIES
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    4-5 EMPLOYEE WERE CLAIMED TO HAVE BROKEN OUT WITH RASHES ON THEIR HANDS AFTER WEARING THE GLOVES. ONE OF THEM WENT TO SEE A PHYSICIAN AND GIVEN PRESCRIPTIVE CREAM TO USE. THE GLOVE WAS NEW TO THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXAM LATEX EXAM POWDER FREE GLOVES LYY SEAL POLYMER INDUSTRIES 8837 4N03K035

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other