BEUDAMED
    FDA Adverse Event Other Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 620460 · Received July 12, 2005

    Report

    Report Number
    2084725-2005-00182
    Event Type
    Other
    Date Received
    July 12, 2005
    Report Date
    July 7, 2003
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    Removal / Correction Number
    Z0051-05
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    USER HAS HAD AN ITCHY RASH ON INNER THIGHS AND UNDER THEIR ARMS FOR OVER A YEAR. THEY WORK WITH THE DISINFECTANT SOLUTION. THEY SOUGHT MEDICAL ATTENTION AND WAS TREATED WITH HYDROCORTISONE CREAM. THE ONLY TIME THE RASH HAS GONE AWAY WAS WHEN THEY WERE ON A THREE WEEK VACATION. THE PROBLEM RESOLVED WHEN NO LONGER WORKING WITH THE SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX OPA SOLUTION DISINFECTANT LRJ ADVANCED STERILIZATION PRODUCTS 20390 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other