BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE IMPACT

    MDR report key: 2030954 · Received March 15, 2011

    Report

    Report Number
    MW5019940
    Event Type
    Injury
    Date Received
    March 15, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 12, 2011
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE USED PER ROUTINE TO DIVIDE BROAD LIGAMENT, HEMORRHAGE REQUIRING LAPAROTOMY, DIFFUSE OOZING REQUIRING OVER-SEWING OF BROAD LIGAMENT AND 5 UNITS OF BLOOD. DIAGNOSIS OR REASON FOR USE: VAGINAL HYSTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT NONE GEI VALLEYLAB 4200

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L