BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIPEN 0.3 MG AUTOINJECTOR

    MDR report key: 2243950 · Received September 2, 2011

    Report

    Report Number
    MW5022147
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 31, 2011
    Report Date
    August 31, 2011
    Manufacturer
    DEYPHARMA
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    EPIPEN BECAME STUCK IN PT AFTER ADMINISTRATION. WHEN FINALLY REMOVED, NEEDLE WAS BENT AND APPEARED TO HAVE A BURR AT THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIPEN 0.3 MG AUTOINJECTOR AUTOINJECTOR KZE DEYPHARMA 06H797

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention