BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX PLUS 28 DAY SOLUTION

    MDR report key: 1071639 · Received July 9, 2008

    Report

    Report Number
    2084725-2008-00366
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 20, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    PMA / PMN Number
    K923744
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN EMPLOYEE RECEIVED AN EYE SPLASH WITH CIDEX IN THE RIGHT EYE WHILE CLEANING A SCOPE. THE EMPLOYEE WAS NOT WEARING AN EYE PROTECTION. IT WAS REPORTED THAT THE EYE WAS "BURNING AND RED AND THE PUPIL WAS ENLARGED, HOWEVER, THERE WERE NO REPORTS OF VISION PROBLEMS." THE EYE WAS RINSED OUT WITH COPIOUS AMOUNTS OF TAP WATER. THE EMPLOYEE WAS ADVISED TO SEEK MEDICAL ATTENTION, HOWEVER, CUSTOMER DID NOT RESPOND TO ASP'S ATTEMPT IN RETRIEVE MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX PLUS 28 DAY SOLUTION BIOCIDES SOLUTIONS (LRJ) LRJ ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR