BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSORB

    MDR report key: 2066602 · Received April 20, 2011

    Report

    Report Number
    2066602
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    March 16, 2011
    Report Date
    April 19, 2011
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH NO SIGNIFICANT MEDICAL HISTORY FELL, SUSTAINING A LEFT TIBIAL PLATEAU FRACTURE WITH EXTENSION INTO THE TIBIAL SHAFT. THE PATIENT UNDERWENT OPEN REDUCTION, INTERNAL FIXATION OF HER LEFT TIBIAL PLATEAU FRACTURE WITH A BUTTRESS PLATE, AND OPEN REDUCTION AND INTERNAL FIXATION OF THE TIBIAL SHAFT WITH PERIARTICULAR PLATE; THE WOUND WAS CLOSED WITH ABSORBABLE SKIN STAPLES. THE PATIENT DEVELOPED MULTIPLE SKIN BLISTERS, NON-VIABLE TISSUE AND A LARGE HEMATOMA REQUIRING REMOVAL OF SKIN STAPLES AND EVACUATION OF THE HEMATOMA WITH MUSCLE FLAP AND SKIN GRAFT. DUE TO NON-HEALING, PATIENT REQUIRED REMOVAL OF HARDWARE AND ABOVE KNEE AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSORB STAPLER, SKIN, ABSORBABLE GDW INCISIVE SURGICAL, INC. 2030 *

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R| S