BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4080795 · Received September 5, 2014

    Report

    Report Number
    MW5038110
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 5, 2014
    Manufacturer
    COVIDIEN
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPERIENCED WARMTH AND THEN BURNING SENSATION IN HER HEAD WHILE IN THE MRI SCANNER WHICH SUBSIDED AFTER REMOVAL FROM THE SCANNER. DATES OF USE: (B)(6) 2014 - (B)(6) 2014. DIAGNOSIS OR REASON FOR USE: BRAIN ANEURYSM. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543268 PIPELINE EMBOLIZATION DEVICE PIPELINE EMBOILZATION DEVICE DQY COVIDIEN 9725255

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR