BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 1111850 · Received August 13, 2008

    Report

    Report Number
    2084725-2008-00510
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MED
    PMA / PMN Number
    K991487
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SOLUTION SPILL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD A "CIDEX SPILL AND IT WAS A WHOLE BOTTLE THAT SPILLED ON THE CARPET." CUSTOMER REPORTED THAT THERE WERE NO PHYSICAL ISSUES. CUSTOMER REPORTED THAT SHE HAD THE SPILL CLEANED UP AND THE MSDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX OPA SOLUTION BIOCIDES SOLUTIONS (MED) MED ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA