BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPI-PEN AUTO INJECTOR

    MDR report key: 1714335 · Received June 3, 2010

    Report

    Report Number
    MW5016265
    Event Type
    Injury
    Date Received
    June 3, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 3, 2010
    Manufacturer
    DEY PHARMA, L.P.
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE NEWLY DESIGNED EPI-PEN HAS AN OBLONG CANISTER AND ORANGE TIP WHICH IS SPRING-LOADED. WHEN MY CHILD TRIED TO SELF-ADMINISTRATOR HER NEW EPI-PEN, SHE WAS UNAWARE THAT A WIDE, VIOLENT SWING WAS REQUIRED TO INJECT THE NEEDLE INTO HER THIGH. THEN, AFTER SHE WAS FINALLY ABLE TO INJECT HERSELF, THE SPRING LOADED ORANGE SHIELD WANTED TO PUSH BACK ON THE THIGH TO RECOVER THE NEEDLE. THE NEEDLE WAS PULLED BACK OUT OF HER THIGH BY THE DEVICE. CONSEQUENTLY, SHE LOST PRECIOUS SECONDS TRYING TO FIGURE OUT HOW TO GET THE NEEDLE INTO HER THIGH AND THEN, DID NOT GET A FULL DOSE DUE TO PREMATURE NEEDLE RETRACTION BY THE DEVICE. THE OLD AUTO-INJECTORS COULD BE ADMINISTERED WITH A SIMPLE FIRM PRESS AGAINST THE OUTSIDE OF THE THIGH, WHICH RELEASED A SPRING LOADED-NEEDLE. DOSE OR AMOUNT: 1 VIAL, FREQUENCY: AS NEEDED, ROUTE: IM. DATES OF USE: (B) (6) 2010 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: ALLERGIC REACTION. EVENT ABATED AFTER USE: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPI-PEN AUTO INJECTOR EPINEPHRINE FMF DEY PHARMA, L.P. 9GM783

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| L