BEUDAMED
    FDA Adverse Event Other Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 625986 · Received August 12, 2005

    Report

    Report Number
    2084725-2005-00192
    Event Type
    Other
    Date Received
    August 12, 2005
    Date of Event
    September 28, 2004
    Report Date
    October 1, 2004
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    Removal / Correction Number
    Z0051-05
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHLEBOTOMIST

    Narratives

    Description of Event or Problem · 1

    PT BEGAN EXPERIENCING LIGHTHEADEDNESS FOLLOWED BY DIZZINESS, SINUS IRRITATION AND HEADACHES WHEN IN THE ROOM WITH THE SCOPE MACHINE WITH DISINFECTANT. THEY REPORTS WEARING PPE. SYMPTOMS RESOLVED AFTER A FILTER WAS CHANGED IN THE SCOPE MACHINE. NO MEDICAL TREATMENT WAS SOUGHT.

    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 20 YR Other