BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2474248 · Received February 28, 2012

    Report

    Report Number
    3007069406-2012-00052
    Event Type
    Other
    Date Received
    February 28, 2012
    Date of Event
    December 9, 2009
    Report Date
    December 8, 2011
    Manufacturer
    PEAK SURGICAL INC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED BASED ON INFO PROVIDED FROM CLINICAL RETROSPECTIVE STUDY. BASED ON THE AVAILABLE SOURCE DOCUMENTATION, THE DURATION OF HOSPITALIZATION IS UNK.

    Description of Event or Problem · 1

    REPORTS OF LOW HEART RATE, AND LOW BLOOD PRESSURE AND AS A RESULT WAS TRANSFERRED TO TELEMETRY AND REMAINED HOSPITALIZED FOR A PROLONGED PERIOD OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI PEAK SURGICAL INC PLASMABLADE 4.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization