BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN NDL 30G 5/16 IN (8MM) SC

    MDR report key: 8560644 · Received April 26, 2019

    Report

    Report Number
    MW5086242
    Event Type
    Injury
    Date Received
    April 26, 2019
    Date of Event
    April 22, 2019
    Report Date
    April 22, 2019
    Manufacturer
    ALLISON MEDICAL, INC.
    Product Code
    FMI
    UDI-DI
    86227011155
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED A NEW BRAND OF NEEDLES. NOW INJECTING NUTROPIN IS PAINFUL AND RESULTS IN A "BUBBLE" BELOW THE SKIN. INJECTION TECHNIQUE IS APPROPRIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351500 PEN NDL 30G 5/16 IN (8MM) SC NEEDLE, HYPODERMIC FMI ALLISON MEDICAL, INC. 86227011155

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR