BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURE COMFORT PEN NEEDLES 31G X 3/16" (5MM)

    MDR report key: 8514506 · Received April 12, 2019

    Report

    Report Number
    MW5085835
    Event Type
    Injury
    Date Received
    April 12, 2019
    Date of Event
    April 6, 2019
    Report Date
    April 6, 2019
    Manufacturer
    ALLISON MEDICAL, INC.
    Product Code
    FMI
    UDI-DI
    86227012105
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT REPORTS THAT HER PEN NEEDLES 31 G X 5MM (NDC NUMBER: (B)(4)) DO NOT WORK WELL WITHIN HER FORTEO PEN. SHE REPORTS THAT IT FITS TOO TIGHT ON HER FORTEO PEN AND HAS MADE IT MORE DIFFICULT FOR HER TO INJECT THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305073 SURE COMFORT PEN NEEDLES 31G X 3/16" (5MM) NEEDLE, HYPODERMIC, SINGLE LUMEN FMI ALLISON MEDICAL, INC. 86227012105

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR