BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURE COMFORT INSULIN SYRINGES

    MDR report key: 3115922 · Received May 12, 2013

    Report

    Report Number
    MW5030179
    Event Type
    Injury
    Date Received
    May 12, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 12, 2013
    Manufacturer
    ALLISON MEDICAL, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE DIABETIC PT WAS USING A "SURE COMFORT" INSULIN SYRINGE NDC 86227070055, LOT# 00730 TO INJECT HIS INSULIN UNDER THE SKIN. UPON NORMAL USE OF THE SYRINGE, THE NEEDLE TIP 5/16" BROKE OFF AND BECAME LODGED UNDER HIS SKIN IN THE AREA OF HIS LOWER LEFT ABDOMEN. THE PT HAS ALREADY MADE TWO URGENT CARE/EMERGENCY ROOM VISITS TO ASSESS REMOVAL OF THE NEEDLE AND WORSENING OF SYMPTOMS. HE IS BEING REFERRED TO A GENERAL SURGEON FOR REMOVAL. HE HAS BEEN STARTED ON ANTIBIOTICS AND PAIN MEDICATION. DIAGNOSIS OR REASON FOR USE: DIABETES, TYPE 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209863 SURE COMFORT INSULIN SYRINGES INSULIN NEEDLE, 1/2CC, SHORT NEEDLE, 30G FMI ALLISON MEDICAL, INC. 22-6005 00730

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention