BEUDAMED
    FDA Adverse Event Other Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 625941 · Received August 12, 2005

    Report

    Report Number
    2084725-2005-00179
    Event Type
    Other
    Date Received
    August 12, 2005
    Report Date
    September 29, 2004
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    Removal / Correction Number
    Z0051-05
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    P1 HAD THEIR FIRST CYSTOSCOPY AND EXPERIENCED BURNING ON URINATION TWO HOURS LATER. THERE WAS SOME IRRITATION AND THE AREA AROUND THE MEATUS WAS REDDENED ON RE-EXAMINATION BY DOCTOR. THE PATIENT WAS UPSET AND LEFT WITH THEIR RECORDS. THE FACILITY HAS SINCE CHANGED BACK TO USING CIDEX PLUS.

    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 66 YR Other