BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPS® BLADE

    MDR report key: 5264699 · Received December 3, 2015

    Report

    Report Number
    1045254-2015-00402
    Event Type
    Injury
    Date Received
    December 3, 2015
    Report Date
    November 11, 2015
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SILVER BULLET BLADE, IT BROKE OFF MID-USE IN THE PATIENT. THE DOCTOR USED FORCEPS TO IMMEDIATELY RETRIEVE THE PIECE WITHOUT ANY COMPLICATION (THE PATIENT WAS UNAFFECTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793620 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC 1884005

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention