BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSURE

    MDR report key: 1526741 · Received November 12, 2009

    Report

    Report Number
    1039144-2009-00024
    Event Type
    Malfunction
    Date Received
    November 12, 2009
    Report Date
    November 12, 2009
    Manufacturer
    HOSUK LTD., C/O MR. YUSHIN KIM
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATED THAT HE EXPERIENCED NEEDLE DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSURE INSULIN SYRINGE FMF HOSUK LTD., C/O MR. YUSHIN KIM 0603-6998-21 5LCE1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK