BEUDAMED
    FDA Adverse Event Summary report: N

    REVITAL-OX RESERT XL HLD HIGH LEVEL DISINFECTANT

    MDR report key: 4325324 · Received December 12, 2014

    Report

    Report Number
    1937531-2014-00012
    Date Received
    December 12, 2014
    Date of Event
    November 12, 2014
    Report Date
    December 12, 2014
    Manufacturer
    STERIS CORPORATION
    Product Code
    MED
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EMPLOYEE SUBJECT OF THE REPORTED EVENT RINSED AND IRRIGATED THE AFFECTED EYE WITH WATER. THE REVITAL-OX RESERT HLD STATES, "IF IN EYES: RINSE CAUTIOUSLY WITH WATER FOR SEVERAL MINUTES. REMOVE CONTACT LENSES, IF PRESENT AND EASY TO DO. CONTINUE RINSING. IF EYE IRRITATION PERSISTS: GET MEDICAL ATTENTION." ACCORDING TO THE SAFETY DATA SHEET, "PERSONAL PROTECTIVE EQUIPMENT: AVOID ALL UNNECESSARY EXPOSURE. [PPE] SHOULD BE SELECTED BASED UPON THE CONDITIONS UNDER WHICH THIS PRODUCT IS HANDLED OR USED. PROTECTIVE CLOTHING. GLOVES. PROTECTIVE GOGGLES." STERIS MADE SEVERAL ATTEMPTS TO CONTACT THE USER FACILITY AND OBTAIN ADDITIONAL INFORMATION REGARDING THEIR EMPLOYEE'S STATUS, HOWEVER, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED AN EMPLOYEE SPLASHED REVITAL-OX RESERT INTO THEIR EYE. STERIS WAS NOT MADE AWARE OF ANY EMPLOYEE INJURY OR IRRITATION IN ASSOCIATION TO THE REPORTED EVENT. NO PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807438 REVITAL-OX RESERT XL HLD HIGH LEVEL DISINFECTANT HIGH LEVEL DISINFECTANT MED STERIS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other