BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHOGAM ULTRA-FILTERED PLUS

    MDR report key: 1916231 · Received December 7, 2010

    Report

    Report Number
    2250051-2010-00259
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 12, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SYRINGE WAS DISCARDED AFTER USE, THEREFORE NO INVESTIGATION WAS PERFORMED. THERE ARE NO SIMILAR COMPLAINTS REGARDING THIS LOT OF PRODUCT. (B)(4).

    Description of Event or Problem · 1

    AFTER ADMINISTERING THE RHOGAM, THE RN REPORTS THAT THE PLUNGER AND SYRINGE DISENGAGED WHILE ACTIVATING THE SAFETY SHIELD, CAUSING THE RN TO FUMBLE AND STICK HERSELF IN THE FOREARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHOGAM ULTRA-FILTERED PLUS RHO (D) IMMUNE GLOBULIN FMI ORTHO CLINICAL DIAGNOSTICS RVP146A1

    Patients

    Seq Age Sex Outcome Treatment
    1