BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERIS

    MDR report key: 382341 · Received March 19, 2002

    Report

    Report Number
    382341
    Event Type
    Other
    Date Received
    March 19, 2002
    Date of Event
    January 31, 2002
    Report Date
    February 12, 2002
    Manufacturer
    STERIS CORP
    Product Code
    FLE
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STERILANT APPEARED TO BE LEAKING OUT OF A VENTED AREA FROM CUP. STAFF NOTED A STRONG ODOR. TWO STAFF WERE TREATED FOR CHEMICAL EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS STERILANT FLE STERIS CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other