BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE COMFORT INSULIN SYRINGE

    MDR report key: 908351 · Received August 31, 2007

    Report

    Report Number
    MW5003634
    Event Type
    Malfunction
    Date Received
    August 31, 2007
    Date of Event
    August 31, 2007
    Report Date
    August 31, 2007
    Manufacturer
    ALLISON MEDICAL INC
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT SAID THAT, WHEN SHE TRIED TO INJECT HERSELF WITH THE NEEDLE, IT BENT AND SHE WASN'T SURE IF SHE RECEIVED HER INSULIN OR NOT. SHE ALSO STATED THAT THE CAPS FALL OFF WHILE STILL IN THE PACKAGE SOMETIMES. DIAGNOSIS OR REASON FOR USE: DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURE COMFORT INSULIN SYRINGE .5CC SYRINGE WITH 5/16IN 31G NEEDLE FOR U-100 INSULIN FMF ALLISON MEDICAL INC 60909

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other