BEUDAMED
    FDA Adverse Event Summary report: N

    VALSURE DETERGENT

    MDR report key: 2476254 · Received March 2, 2012

    Report

    Report Number
    1937531-2012-00001
    Date Received
    March 2, 2012
    Date of Event
    February 2, 2012
    Report Date
    March 2, 2012
    Manufacturer
    STERIS CORPORATION
    Product Code
    LRJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETENTION TESTING COMPLETED ON THE LOT SUBJECT OF THE REPORTED EVENT EVIDENCED PASSING RESULTS; NO ISSUES WERE NOTED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED. STERIS INSPECTED THE DISPENSERS AND NOTED THEY WERE NOT PROPERLY CALIBRATED AND WERE DISPENSING TOO MUCH PRODUCT, RESULTING IN EXCESSIVE VAPORS IN THE AREA THE PRODUCT WAS BEING USED. THE DISPENSERS WILL BE RECALIBRATED TO ENSURE THEY ARE DISPENSING THE CORRECT AMOUNT OF PRODUCT. STERIS HAS DETERMINED THIS TO BE AN ISOLATED EVENT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT STAFF MEMBERS ARE EXPERIENCING HEADACHES WHEN USING THE PRODUCT. THE FACILITY REPORTED THAT SOME EMPLOYEES WENT HOME EARLY DUE TO INHALATION SYMPTOMS, BUT THEY ARE FINE WITH NO SUSTAINING INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALSURE DETERGENT DISINFECTANT LRJ STERIS CORPORATION 259729

    Patients

    Seq Age Sex Outcome Treatment
    1 Other