BEUDAMED
    FDA Adverse Event Other Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 624093 · Received August 3, 2005

    Report

    Report Number
    2084725-2005-00211
    Event Type
    Other
    Date Received
    August 3, 2005
    Report Date
    September 18, 2000
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    Removal / Correction Number
    Z0051-05
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAS HAD REPEATED RESPIRATORY ILLNESS FOR PAST FOUR MONTHS WHICH IS THE LENGTH OF TIME CIDEX OPA HAS BEEN IN USE. PT HAS SEEN BOTH PHYSICIAN AND EMPLOYEE HEALTH. PT HAS BEEN DIAGNOSED WITH PNEUMONIA. THE FACILITY DISCOVERED THAT THE AIR EXHAUST SYSTEM HAD BEEN TURNED OFF FOR AN UNK LENGTH OF TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other