BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX PLUS 28 DAY SOLUTION

    MDR report key: 1060230 · Received June 12, 2008

    Report

    Report Number
    2084725-2008-00277
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 21, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN EMPLOYEE WAS SPLASHED IN HER LEFT EYE WHEN USING THE CIDEX PLUS. THE EYE WAS RINSED WITH 2 LITERS OF SALINE. THE EMPLOYEE WAS WEARING EYE GLASSES AND GLOVES. THE EMPLOYEE SOUGHT MEDICAL ATTENTION, HOWEVER, IT IS UNK IF MEDICATION WAS GIVEN.

    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 UNK