BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM OCCLUSION BALLOON SYSTEM

    MDR report key: 2972201 · Received February 21, 2013

    Report

    Report Number
    2029214-2013-00137
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 23, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WAS RETURNED FOR EVALUATION AND THE PACKAGE WAS FOUND UNSEALED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HYPERFORM BALLOON POUCH WAS NOT SEALED; THEREFORE, THE DEVICE WAS NOT USED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76117 HYPERFORM OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON SYSTEM MJN EV3 NEUROVASCULAR 104-4470 9657597

    Patients

    Seq Age Sex Outcome Treatment
    1