BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 2170644 · Received July 18, 2011

    Report

    Report Number
    MW5021377
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Date of Event
    April 12, 2011
    Report Date
    June 9, 2011
    Manufacturer
    MEDTRONIC, ENT DIV
    Product Code
    HAO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN EAR PROCEDURE, THE TIP OF AN INSTRUMENT BROKE OFF IN THE PT'S EAR. ANOTHER INSTRUMENT WITH A MAGNET AT THE END OF IT WAS USED TO RETRIEVE THE METAL TIP. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC 90DEG STRUT PICK HAO MEDTRONIC, ENT DIV

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR