BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX OPA SOLUTION TEST STRIPS

    MDR report key: 1495360 · Received September 1, 2009

    Report

    Report Number
    8021896-2009-00013
    Event Type
    Malfunction
    Date Received
    September 1, 2009
    Date of Event
    January 1, 2009
    Report Date
    August 12, 2009
    Manufacturer
    ALBERT BROWNE LTD.
    Product Code
    JOJ
    PMA / PMN Number
    K991709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNK.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A CUSTOMER HAS BEEN USING AN EXPIRED BOTTLE OF CIDEX OPA TEST STRIPS. THE CUSTOMER INQUIRED ABOUT THE EFFECTIVENESS OF THE PRODUCT USED 90 DAYS PAST ITS EXPIRATION DATE. A CUSTOMER CARE CENTER (CCC) ASSOCIATE PROVIDED HIM WITH THE PRODUCT IFU INFO. HE WAS INFORMED THAT PRODUCT EFFICACY CANNOT BE GUARANTEED IF USED 90 DAYS PAST ITS EXPIRATION DATE. THE CUSTOMER STATED THAT TO DATE, NO PT REACTIONS HAVE BEEN REPORTED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX OPA SOLUTION TEST STRIPS BIOCIDES TEST STRIPS (JOJ) JOJ ALBERT BROWNE LTD. NA 014722

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK