BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSURE MAXI COMFORT ULTRA THIN 1ML SYRINGE

    MDR report key: 1180477 · Received September 29, 2008

    Report

    Report Number
    MW5008483
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 2008
    Manufacturer
    ACCUSURE
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    INSULIN SYRINGES THAT NEEDLE PULLS OUT AND REMAINS IN PT AFTER GIVING INJECTION OF SUBQ DOSE. DIAGNOSIS OR REASON FOR USE: DIABETIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSURE MAXI COMFORT ULTRA THIN 1ML SYRINGE INSULIN NEEDLE AND SYRINGE FMF ACCUSURE * A07001

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability