BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIPEN

    MDR report key: 1897349 · Received November 5, 2010

    Report

    Report Number
    MW5018113
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 17, 2010
    Report Date
    October 23, 2010
    Manufacturer
    DEY LAB
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SUFFERING ANAPHYLACTIC REACTION FROM FOOD ALLERGY. INJECTED WITH EPI-PEN. NEEDLE BENT TO EXTREME ANGLE IN LEG MUSCLE. VERY DIFFICULT TO WITHDRAW NEEDLE. CAUSED INCREASED PAIN AND BRUISING AT INJECTION SITE. DOSE OR AMOUNT: 0.3 MG, FREQUENCY: PRN, ROUTE: IM. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: ANAPHYLAXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIPEN EPIPEN FMI DEY LAB 9EN321

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR