BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX PLUS 28 DAY SOLUTION

    MDR report key: 1140573 · Received August 28, 2008

    Report

    Report Number
    2084725-2008-00553
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 30, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MED
    PMA / PMN Number
    K923744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAKING FROM CONTAINER.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED LEAKAGE OF SOLUTION FROM THE BOTTLE. THE LEAKAGE WAS FOUND BEFORE THE BOTTLE WAS OPENED AND WHILE IT WAS STILL IN THE CARTON. THE AFFILIATE STATED THAT THERE WERE NO PHYSICAL COMPLAINTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX PLUS 28 DAY SOLUTION HIGH-LEVEL DISINFECTANT MED ADVANCED STERILIZATION PRODUCTS NA 039HF

    Patients

    Seq Age Sex Outcome Treatment
    1 NA