BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAD NASAL

    MDR report key: 2243942 · Received September 6, 2011

    Report

    Report Number
    MW5022155
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Report Date
    September 6, 2011
    Manufacturer
    WOLFE TORY MEDICAL, INC.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    MUCOSAL ATOMIZATION DEVICE IS LABELED AS "NOT FOR IV USE." PER (B)(6), PRODUCTS/DRUGS SHOULD ONLY BE LABELED AS "FOR __ USE," AS OPPOSED TO "NOT FOR __ USE." IMPROPER LABELING OF DEVICE COULD POTENTIALLY LEAD TO MEDICATION ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAD NASAL MUCOSAL ATOMIZATION DEVICE CCQ WOLFE TORY MEDICAL, INC. 10315A

    Patients

    Seq Age Sex Outcome Treatment
    1