BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURE COMFORT SYRINGE

    MDR report key: 5843069 · Received August 1, 2016

    Report

    Report Number
    MW5063808
    Event Type
    Injury
    Date Received
    August 1, 2016
    Report Date
    August 1, 2016
    Manufacturer
    ALLISON MEDICAL, INC.
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER REPORTED THAT, HE HAS INSULIN NEEDLE U-100, 1CC SYRINGE, 1/2 INCH LONG 30 GAUGE. WHEN HE INJECT HIS ABDOMEN, IT COMES OUT OF 45 DEGREE ANGLE AND HE BLEEDS AT THE INJECTION SITE. THE NEEDLE IS BENT IN HIS BODY TO A 45 DEGREE ANGLE INSTEAD OF STRAIGHT. HE SAID THIS WAS NOT THE CASE WITH BD SYRINGES THAT HE WAS USING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490227 SURE COMFORT SYRINGE INSULIN SYRINGE FMF ALLISON MEDICAL, INC. 51220

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR