BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICHOICE UNISTIK 3 NORMAL

    MDR report key: 4652283 · Received March 26, 2015

    Report

    Report Number
    1058602-2015-00004
    Event Type
    Injury
    Date Received
    March 26, 2015
    Date of Event
    February 1, 2015
    Report Date
    February 24, 2015
    Manufacturer
    OWEN MUMFORD LTD
    Product Code
    FMK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DEVICE DID NOT RETRACT AND THERE IS A REPORTED ACCIDENTAL NEEDLE STICK. ATTEMPTING TO GATHER ADDITIONAL INFORMATION FROM FACILITY MULTIPLE ATTEMPTS HAVE GONE UNANSWERED. REF MFR # 8021764-2015-00004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202007 MEDICHOICE UNISTIK 3 NORMAL SAFETY LANCET FMK OWEN MUMFORD LTD MC 5030 J4982

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other