BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA FINE 31G X 8MM INSULIN PEN NEEDLE

    MDR report key: 3854906 · Received May 28, 2014

    Report

    Report Number
    2243072-2014-00108
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BD
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE SAMPLE HAS BEEN MADE; IT IS UNKNOWN AT THIS POINT IF THE SAMPLE WILL BE RETURNED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A PATIENT WHO HAD RECENTLY BEGAN USING THE 320109 PRODUCT DEVELOPED A RASH AFTER USING THE DEVICE. THE PATIENT'S MOTHER DOES THE INJECTIONS AND WIPES THE AREA WITH ALCOHOL PRIOR TO EACH INJECTION. THE PATIENT HAS A COBALT ALLERGY. THE PATIENT WENT TO A DERMATOLOGIST AND AN ALLERGIST AND THE RASH WAS TREATED WITH A TOPICAL STEROID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315137 BD ULTRA FINE 31G X 8MM INSULIN PEN NEEDLE PEN NEEDLE, 31G X 8MM FMI BD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention