BEUDAMED
    FDA Adverse Event Other Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 620381 · Received July 12, 2005

    Report

    Report Number
    2084725-2005-00206
    Event Type
    Other
    Date Received
    July 12, 2005
    Report Date
    April 24, 2003
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    Removal / Correction Number
    Z0051-05
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    E1 REPORTED COUGHING, DIFFICULTY BREATHING AND A RASH ON THEIR ARMS AND CHEST. THEY WORK WITH CIDEX OPA AND WEARS PPE. THEY WERE SEEN BY A PHYSICIAN AND DIAGNOSED WITH CHEMICAL BRONCHITIS. TREATMENT IS UNKNOWN.

    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