BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUAMANTYS 6.0 BIPOLAR SEALER

    MDR report key: 2467843 · Received February 16, 2012

    Report

    Report Number
    1226420-2012-00003
    Event Type
    Injury
    Date Received
    February 16, 2012
    Date of Event
    January 19, 2012
    Report Date
    February 17, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PUBLISHED POSTER ABSTRACTION FROM 2012 AAOS MEETING INDICATED INSTANCES OF PARESTHESIAS IN TKA PROCEDURES UTILIZING AQUAMANTYS BIPOLAR SEALERS (10 PTS IN TOTAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUAMANTYS 6.0 BIPOLAR SEALER AQUAMANTYS 6.0 BIPOLAR SEALER GEI MEDTRONIC ADVANCED ENERGY, LLC 23-112-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other