BEUDAMED
    FDA Adverse Event Other Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 628568 · Received August 19, 2005

    Report

    Report Number
    2084725-2005-00221
    Event Type
    Other
    Date Received
    August 19, 2005
    Report Date
    December 4, 2001
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    Removal / Correction Number
    Z0051-05
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT REPORTED SYMPTOMS OF HEADACHES, RESPIRATORY CONGESTION AND BRONCHITIS IN THE AREA WHERE THE CIDEX OPA WAS USED. MEDICAL ATTENTION WAS SOUGHT AND A CHEST X-RAY WAS DONE. IT WAS FOUND THAT THE VENTILATION SYSTEM HAD MALFUNCTIONED, IT WAS FIXED BY MAINTENANCE AND THE SITUATION IMPROVED.

    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