BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIPEN

    MDR report key: 5999463 · Received October 3, 2016

    Report

    Report Number
    MW5065183
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    October 1, 2016
    Report Date
    October 3, 2016
    Manufacturer
    MYLAN / PHARMACEUTICALS INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER STATED THAT ON SATURDAY (B)(6) 2016 SHE HAD AN EMERGENCY REACTION TO A FOOD ALLERGY. SHE STARTED EXPERIENCING HER THROAT CLOSING AND QUICKLY GRABBED HER EPIPEN TO INJECT HERSELF AND THE DEVICE JAMMED. FORTUNATELY, SHE HAD A SPARE EPIPEN THAT WORKED EVEN THOUGH IT EXPIRED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644497 EPIPEN EPIPEN FMF MYLAN / PHARMACEUTICALS INC. 6GM063
    644498 EPIPEN EPIPEN FMF MYLAN 4GM277

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention