BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 1140676 · Received August 28, 2008

    Report

    Report Number
    2084725-2008-00549
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MED
    PMA / PMN Number
    K991487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE NOT USING TEST STRIPS TO TEST THE SOLUTION BEFORE USE. THE CUSTOMER DID NOT PROVIDE INFORMATION REGARDING POTENTIAL PATIENT INJURY. ATTEMPTED TO CONTACT THE PATIENT TO GATHER ADDITIONAL INFORMATION BUT THE CUSTOMER WAS NOT AVAILABLE.

    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 UNK CIDEX OPA TEST STRIPS