BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIXTRA 2.5

    MDR report key: 1789288 · Received August 2, 2010

    Report

    Report Number
    MW5016982
    Event Type
    Malfunction
    Date Received
    August 2, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 2, 2010
    Manufacturer
    GSK
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ARIXTRA SYRINGE EXPLODED WHEN NURSE WAS EXPLAINING TO PATIENT HOW TO INJECT HERSELF. THE SPRING LOADED PART SHOT OFF JUST MISSING THE PATIENT'S FACE AND HIT THE WALL AND BOUNCED BACK AT THE NURSE. DOSE OR AMOUNT: 0.5ML, FREQUENCY: DAILY, ROUTE: SUBCONJUNCTIVAL. DATES OF USE: (B)(6)2010 - (B)(6)2010. DIAGNOSIS OR REASON FOR USE: DVT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIXTRA 2.5 SYRINGE FMF GSK 3036A

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other