BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSURE

    MDR report key: 1558623 · Received December 9, 2009

    Report

    Report Number
    1039144-2009-00027
    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
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATED THAT HER HUSBAND HAS HAD SIX NEEDLES BECOME DETACHED AND TWO NEEDLES REMAIN IN HIS ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSURE INSULIN SYRINGE FMF SHIN CHANG MEDICAL CO., LTD. 0603-6998-21 SD0347

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK