BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFINE PENTIPS 8MM

    MDR report key: 4768657 · Received April 29, 2015

    Report

    Report Number
    1058602-2015-00006
    Event Type
    Injury
    Date Received
    April 29, 2015
    Date of Event
    April 13, 2015
    Report Date
    April 15, 2015
    Manufacturer
    OWEN MUMFORD LTD
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATES THAT AFTER INJECTION SHE PULLED THE PEN AWAY FROM HER SKIN AND NOTICED THE NEEDLE WAS EMBEDDED INTO HER SKIN. SHE WENT TO THE EMERGENCY ROOM TO HAVE THE NEEDLE REMOVED BUT LEFT BEFORE BEING SEEN BY A DOCTOR BECAUSE THE EMERGENCY ROOM WAS TOO BUSY. SHE STATED SHE HAD AN APPOINTMENT WITH HER REGULAR DOCTOR ON (B)(6). A MEDICAL QUESTIONNAIRE WAS EMAILED TO THE CONSUMER AND REQUEST FOR COMPLETION AND RETURN OF THE DOCUMENTATION AND THE RETURN OF THE OFFENDING DEVICES. F/U WITH THE CONSUMER ON 04/22/2015, THE CONSUMER STATES THAT SHE WENT TO HER REGULAR DOCTOR AND THAT THE NEEDLE IS STILL IN HER STOMACH BECAUSE HER DOCTOR CANNOT REMOVE BECAUSE IT IS TOO DEEP AND MAY BE IT WILL COME OUT ON ITS OWN. CONSUMER STATED THAT SHE HAS HAD (B)(6) AND STAPH TWICE AND DOCTORS ARE HESITANT TO CUT ON HER. MFR #: 8021764-2015-00006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283655 UNIFINE PENTIPS 8MM PEN NEEDLES FMI OWEN MUMFORD LTD AN 3530 1404736.K197

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other