BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX OPA SOLUTION TEST STRIPS (60 STRIPS/BOTTLE)

    MDR report key: 1495288 · Received September 1, 2009

    Report

    Report Number
    8021896-2009-00014
    Event Type
    Malfunction
    Date Received
    September 1, 2009
    Date of Event
    January 1, 2009
    Report Date
    August 17, 2009
    Manufacturer
    ALBERT BROWNE LTD.
    Product Code
    JOJ
    PMA / PMN Number
    K991709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    ADDITIONAL INFO IDENTIFYING THE LOT #S OF THE EXPIRED CIDEX OPA TEST STRIPS WAS RECENTLY RECEIVED. THIS COMPLAINT FILE WAS OPENED FOR THE 2ND LOT #. ACCORDING TO THE OR MGR, THE # OF PTS WHO MAY HAVE HAD A REACTION IN ASSOCIATION WITH THIS USAGE IS UNK. RECENTLY, THEY HAD FOUR SURGICAL PTS BUT NO ADVERSE EFFECTS HAVE BEEN REPORTED. THEY ARE NOW USING CIDEX OPA TEST STRIPS WITHIN THEIR EXP DATE AND NO PROBLEMS HAVE BEEN OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX OPA SOLUTION TEST STRIPS (60 STRIPS/BOTTLE) BIOCIDES TEST STRIPS (JOJ) JOJ ALBERT BROWNE LTD. NA 016103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA