BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSURE

    MDR report key: 1526744 · Received November 12, 2009

    Report

    Report Number
    1039144-2009-00023
    Event Type
    Malfunction
    Date Received
    November 12, 2009
    Report Date
    November 12, 2009
    Manufacturer
    SHIN CHANG MEDICAL CO., LTD.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    STATED THAT ABOUT A YEAR AGO WHILE USING THE ACCUSURE SYRINGES, THE NEEDLE BECAME DETACHED. HE CALLED QUALITEST TO ISSUE A COMPLAINT AND REC'D TWO REPLACEMENT BOXES OF SYRINGES. ABOUT SIX MONTHS LATER, HE HAD THE SAME PROBLEM WITH THE SYRINGES. HE HAD ANOTHER COMPLAINT AND REC'D TWO REPLACEMENT BOXES. HE HAS FOUR BOXES OF ACCUSURE SYRINGES THAT ARE BEING RECALLED AND HIS LOCAL (B)(6) WILL NOT RETURN HIS SYRINGES BECAUSE THE PHARMACY NO LONGER STOCKS ACCUSURE SYRINGES. HIS PHARMACY TOLD HIM THEY WOULD NOT BE ABLE TO HELP HIM IN REPLACING HIS SYRINGES AND FOR HIM TO CONTACT QUALITEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSURE INSULIN SYRINGE FMF SHIN CHANG MEDICAL CO., LTD. 0603-6995-21 SD0288

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK