BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANTI-D IGM-IGG (MONOCLONAL BLEND)

    MDR report key: 463645 · Received May 27, 2003

    Report

    Report Number
    1623424-2003-00001
    Event Type
    Other
    Date Received
    May 27, 2003
    Date of Event
    August 13, 2001
    Report Date
    May 27, 2003
    Manufacturer
    GAMMA BIOLOGICALS, INC.
    Product Code
    KSZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    A RH NEGATIVE (-) PATIENT WAS TRANSFUSED WITH RH POSITIVE (-) PACKED RED BLOOD CELL UNITS THAT PRESUMABLY STIMULATED AN ANTI-D ANTIBODY RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-D IGM-IGG (MONOCLONAL BLEND) RH BLOOD GROUPING REAGENT KSZ GAMMA BIOLOGICALS, INC. NA DMB27-1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other