BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSURE

    MDR report key: 1526752 · Received November 12, 2009

    Report

    Report Number
    1039144-2009-00020
    Event Type
    Injury
    Date Received
    November 12, 2009
    Report Date
    November 12, 2009
    Manufacturer
    SHIN CHANG MEDICAL CO., LTD.
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SYRINGE BENT DURING ADMINISTERING INSULIN AND LEFT A BRUISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSURE INSULIN SYRINGE FMF SHIN CHANG MEDICAL CO., LTD. 0603-6999-21 SD0361

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK