BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIFINE PENTIPS

    MDR report key: 1943547 · Received December 3, 2010

    Report

    Report Number
    8021764-2010-00004
    Event Type
    Other
    Date Received
    December 3, 2010
    Date of Event
    November 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    OWEN MUMFORD, LTD.
    Product Code
    FMI
    PMA / PMN Number
    K983994
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING THE RETURN OF THE PRODUCT AND A QUESTIONNAIRE SENT TO THE PT IN ORDER TO GATHER MORE DETAILS ABOUT THE EVENT.

    Description of Event or Problem · 1

    THE USER STATED: HE INJECTED HIMSELF YESTERDAY MORNING & THE NEEDLE DETACHED IN HIS BODY. HE STATED HE WENT TO THE ER & THE NEEDLE WAS FOUND VIA IMAGING; REFERRED TO SURGEON. SURGEON UNABLE TO REMOVE NEEDLE. HE HAS AN ALTERNATIVE WAY OF ADMINISTERING HIS INULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIFINE PENTIPS UNIFINE PENTIPS FMI OWEN MUMFORD, LTD. AN 3530 0910742.A600

    Patients

    Seq Age Sex Outcome Treatment
    1 Other