BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUAMANTYS 2.3 BIPOLAR SEALER / AQUAMANTYS EVS

    MDR report key: 2211403 · Received August 8, 2011

    Report

    Report Number
    1226420-2011-00011
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 8, 2011
    Manufacturer
    SALIENT SURGICAL TECHNOLOGIES, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES UNAVAILABLE TO RETURN TO MFR FOR INVESTIGATION.

    Description of Event or Problem · 1

    LUMBAR WOUND INFECTION. WOULD CULTURE REVEALED INFECTION WAS (B)(4) AND (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUAMANTYS 2.3 BIPOLAR SEALER / AQUAMANTYS EVS AQUAMANTYS 2.3 / AQUAMANTYS EVS GEI SALIENT SURGICAL TECHNOLOGIES, INC. 23-112-1 / 23-121-1

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other