BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.8% SURGISCREEN

    MDR report key: 2103248 · Received May 25, 2011

    Report

    Report Number
    2250051-2011-00115
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED A BATCH REVIEW OF THIS LOT. SATISFACTORY RESULTS WERE OBSERVED. A COMPLAINT REVIEW WAS PERFORMED. THERE ARE NO SIMILAR COMPLAINTS AGAINST THIS LOT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED NO REACTIVITY WITH VSS376 AND A PATIENT SAMPLE WITH ANTI-E. IS CROSSMATCH WAS PERFORMED. PATIENT WAS TRANSFUSED 9 UNITS OF BLOOD. PATIENT EXPERIENCED A TRANSFUSION REACTION. CUSTOMER INDICATED THAT 3 OF THE 9 UNITS WERE E+.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SURGISCREEN REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VSS376

    Patients

    Seq Age Sex Outcome Treatment
    1 Other