BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOTWIST 30G

    MDR report key: 5825540 · Received July 24, 2016

    Report

    Report Number
    MW5063665
    Event Type
    Injury
    Date Received
    July 24, 2016
    Date of Event
    July 21, 2016
    Report Date
    July 24, 2016
    Manufacturer
    NOVO NORDISK, INC.
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY ALMOST (B)(6) DAUGHTER WAS INJECTING HER MEDICINE (NORDITROPIN) IN HER THIGH AS SHE HAS FOR THE LAST (APPROX) 2 YEARS. PRIOR, THE NEEDLE (NOVOTWIST 30G X 8MM) HAD BROKEN OFF TWICE WITHIN THE LAST MONTH, BUT WAS STILL ON THE SURFACE (A TINY BIT) AND COULD BE PULLED OUT. I'M UNSURE AT THIS MOMENT WHAT LOT NUMBER THESE NEEDLES WERE FROM; THE BOX IS STILL AT HER FATHER'S HOUSE AND WILL BE RETRIEVED SHORTLY. ON (B)(6) 2016 APPROX 7:30 PM, THE NEEDLE BROKE OFF (LOT 15A15N) AND COULDN'T BE RETRIEVED BY PARENTS. THE CHILD WAS TAKEN TO THE EMERGENCY ROOM. SHE WAS EXAMINED, AND THEY COULDN'T SEE THE NEEDLE; MULTIPLE XRAYS SHOWED THE NEEDLE WAS TOO DEEP TO RETRIEVE. IT WAS DETERMINED IT SHOULD BE LEFT UNEXTRACTED FROM HER THIGH. SHE IS IN PAIN, AND LEFT THE ER WITH CRUTCHES. SHE CONTINUES TO BE IN PAIN WHEN SHE WALKS OR MOVES HER LEG. I REPORTED THIS TO THE MFR (NOVO NORDISK INC) ON FRIDAY; THEY SEEMED LARGELY UNCONCERNED AND WERE NOT FORTHCOMING WITH INFO ABOUT WHAT NEEDLES ARE A PROBLEM (SO I'D KNOW WHAT KIND OF NEEDLES TO USE IN THE FUTURE). THEY ALSO SAID THEY'D ARRANGE WITH THE PHARMACY TO GET A NEW TYPE OF NEEDLE OVERNIGHT TO ME, BUT THEY DIDN'T PROPERLY FOLLOW THROUGH. THE MFR WAS NO HELP, AND PROVIDED NO ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471471 NOVOTWIST 30G NOVOTWIST 30G FMI NOVO NORDISK, INC. 15A15N
    471472 NOVOTWIST 30G NOVOTWIST 30G FMI NOVO NORDISK
    471473 NOVOTWIST 30G NOVOTWIST 30G FMI NOVO NORDISK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other| R| S