BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSURE

    MDR report key: 1368335 · Received April 17, 2009

    Report

    Report Number
    1039144-2009-00004
    Event Type
    Malfunction
    Date Received
    April 17, 2009
    Date of Event
    April 16, 2009
    Report Date
    April 17, 2009
    Manufacturer
    SHIN CHANG MEDICAL CO., LTD.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT STATES THAT "THE INDIVIDUAL SYRINGE PACKAGING IS VERY CLOUDY, ALMOST LIKE CONDENSATION IS IN THE PACKAGING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSURE INSULIN SYRINGE FMF SHIN CHANG MEDICAL CO., LTD. 1/2 CC/29 GAUGE SD0335

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK