BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SURGISCREEN FOR GEL

    MDR report key: 1981467 · Received February 8, 2011

    Report

    Report Number
    2250051-2011-00025
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 18, 2011
    Report Date
    February 8, 2011
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAINED TESTING. SATISFACTORY RESULTS WERE OBSERVED. CUSTOMER STATED THAT NO ERRONEOUS RESULTS HAD BEEN REPORTED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT NO REACTIVITY WAS OBSERVED WITH A PATIENT SAMPLE CONTAINING ANTI-E AND (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SURGISCREEN FOR GEL REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1