BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX OPA SOLUTION TEST STRIPS

    MDR report key: 1395173 · Received March 31, 2009

    Report

    Report Number
    8021896-2009-00010
    Event Type
    Malfunction
    Date Received
    March 31, 2009
    Date of Event
    March 2, 2009
    Report Date
    March 2, 2009
    Manufacturer
    ALBERT BROWNE LTD.
    Product Code
    JOJ
    PMA / PMN Number
    K991709
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIPS. REF MDR: 2150060-2009-00047, 2150060-2009-00048.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THE CIDEX OPA TEST STRIPS FAILED STERILIZATION TESTS. THE CUSTOMER STATED THAT NO INJURIES WERE INVOLVED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA CIDEX OPA SOLUTION