BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIMED

    MDR report key: 1000010 · Received February 12, 2008

    Report

    Report Number
    MW5005535
    Event Type
    Malfunction
    Date Received
    February 12, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 12, 2008
    Manufacturer
    ULTI-MED, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT STATES ULTI-MED 0.5ML LOW DOSE INSULIN SYRINGE IS DEFECTIVE. PT STATES THE INCREMENTS ON THE SYRINGE CLOSEST TO THE NEEDLE ARE INCORRECT BECAUSE THE FIRST LINE IS VERY CLOSE TO THE NEEDLE. HE SOMETIMES USES LOW DOSES OF INSULIN - 3 OR 4 UNITS - AND FEELS THAT THE MEASUREMENTS ARE NOT CORRECT BECAUSE THE INCREMENT FOR THE FIRST UNIT IS SMALLER THAN THE OTHER INCREMENTS. DOSE OR AMOUNT: 1 SYRINGE, FOUR TIMES A DAY, SQ. DIAGNOSIS OR REASON FOR USE: DIABETES RQUIRING INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMED INSULIN SYRINGE FMF ULTI-MED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR