BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFINE PENTIPS 8MM

    MDR report key: 3554529 · Received December 20, 2013

    Report

    Report Number
    1058602-2013-00006
    Event Type
    Injury
    Date Received
    December 20, 2013
    Report Date
    December 20, 2013
    Manufacturer
    OWEN MUMFORD LTD
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    END USER WAS CONTACTED ON (B)(6) 2013 AFTER AN E-MAIL WAS RECEIVED. MEDICAL QUESTIONNAIRE RECEIVED STATES SHE INJECTED HER INSULIN IN HER STOMACH THE WEEK OF (B)(6) 2013 AND WHEN SHE PULLED IT OUT TO MAKE SURE THE INSULIN WAS DISPENSED, SHE NOTICED THERE WAS NO NEEDLE. SHE SEARCHED THE IMMEDIATE AREA AND COULD NOT FIND IT. SHE CALLED THE DOCTOR THE NEXT DAY AND MADE AN APPOINTMENT FOR (B)(6) 2013. SHE WAS SENT FOR X-RAYS AND THIS DR MADE APPOINTMENT WITH A SURGEON ON (B)(6) 2013. THE OUTPATIENT SURGERY WAS PERFORMED ON (B)(6) 2013. THE SURGEON TRIED FOR AN HOUR USING X-RAY MACHINE FOR LOCATION BUT COULD NOT REMOVE IT. THE SURGEON ADVISED END USER TO WAIT FOR THE PENTIP TO COME OUT ON ITS OWN. NOW WHEN SHE USES HER STATIONARY EXERCISE BIKE AND PEDALS SHE GETS POKED, BUT IT DOES NOT CAUSE PAIN. REFERENCE MFR REPORT # 8021764-2013-00006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669079 UNIFINE PENTIPS 8MM PEN NEEDLES FMI OWEN MUMFORD LTD AN 3530 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other INSULIN