BEUDAMED
    FDA Adverse Event Other Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 628576 · Received August 19, 2005

    Report

    Report Number
    2084725-2005-00218
    Event Type
    Other
    Date Received
    August 19, 2005
    Report Date
    October 22, 2001
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    Removal / Correction Number
    Z0051-05
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED IRRITATION TO NOSE, NUMBNESS AND TINGLING TO LIPS, DRY COUGH, AND EYES BURNING WHEN EXPOSED TO CIDEX OPA. NO MEDICAL ATTENTION INDICATED. USER CHANGED TO CIDEX 14 DAY SOLUTION AND SYMPTOMS RESOLVED.

    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