BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILANT CONCENTRATE

    MDR report key: 31976 · Received April 12, 1996

    Report

    Report Number
    MW1008870
    Event Type
    Malfunction
    Date Received
    April 12, 1996
    Date of Event
    April 4, 1996
    Report Date
    April 9, 1996
    Manufacturer
    STERIS CORP.
    Product Code
    FLF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON OR NURSE'S AIDE (NA) CONTACT WITH MFR'S STERILANT CONTAINER FOR PLACEMENT IN MFR'S STERILANT MACHINE, CONTAINER SPONTANEOUSLY OPENED, RESULTING IN SPILLAGE OF SOLUTION ONTO NA AND SPREAD OF FUMES. NA EVALUATED IN ER AND ADMITTED TO HOSP OVERNIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILANT CONCENTRATE STERILANT CONCENTRATE FLF STERIS CORP. 202-60116

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO