BEUDAMED
    FDA Adverse Event Other Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 632055 · Received August 29, 2005

    Report

    Report Number
    2084725-2005-00381
    Event Type
    Other
    Date Received
    August 29, 2005
    Report Date
    August 4, 2003
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    Removal / Correction Number
    Z0051-05
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HEALTHCARE WORKER EXPERIENCED UNSPECIFIED CONGESTION WHILE WORKING IN A ROOM WHERE CIDEX IS USED FOR 8 HOURS. THE WORKER'S FAMILY ALSO COMPLAINED THEY SMELL "LIKE CHEMICALS" WHEN THEY RETURNED HOME FROM WORK. THIS WORKER IS SYMPTOM-FREE ON THE WEEKEND. A CO-WORKER SAID THEY WERE INFORMED THE AIR EXCHANGE IN THE ROOM WAS ADEQUATE. THE ROOM REPORTEDLY HAS A VENT IN THE CEILING AND A WALL MOUNTED FAN. ACCORDING TO THE CO-WORKER, THE AMOUNT OF AIR EXCHANGED WAS REPORTED AS "420 CUBIC SQUARE" PER MINUTE.

    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