BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSURE

    MDR report key: 1558627 · Received December 9, 2009

    Report

    Report Number
    1039144-2009-00026
    Event Type
    Injury
    Date Received
    December 9, 2009
    Report Date
    December 9, 2009
    Manufacturer
    SHIN CHANG MEDICAL CO., LTD.
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATED THAT ON SEVERAL OCCASIONS WHILE USING ACCUSURE INSULIN SYRINGES, THE NEEDLE BECAME DETACHED FROM THE SYRINGE. SHE STATED THAT SHE LOOKED FOR THE NEEDLE ON THE FLOOR, BUT NEVER FOUND THE NEEDLE. SHE THINKS THE NEEDLE HAS REMAINED IN HER STOMACH AND IS CONCERNED THAT IT COULD CAUSE INTERNAL DAMAGE TO HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSURE INSULIN SYRINGE FMF SHIN CHANG MEDICAL CO., LTD. 0603-6998-21 SD0299

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK