BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTEGRA MATRIX WOUND DRESSING 2X2 SINGLE DOMESTIC

    MDR report key: 1912881 · Received November 10, 2010

    Report

    Report Number
    1121308-2010-00024
    Event Type
    Other
    Date Received
    November 10, 2010
    Date of Event
    September 3, 2010
    Report Date
    November 10, 2010
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    KGN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE RPTR STATED THAT AN ELDERLY FEMALE PT HAD TWO INTEGRA MATRIX WOUND DRESSINGS APPLIED DURING A REAR PELVIC DECUBITUS ULCER PROCEDURE. POST OPERATIVELY, NURSING STAFF OBSERVED THAT THE VACUUM ASSISTED CLOSURE DRAIN PULLED THROUGH A NOTICEABLE AMOUNT OF BLOOD, AND SUBSEQUENTLY, THE PT UNDERWENT A SECOND SURGICAL PROCEDURE TO STOP THE WOUND HEMORRHAGE. THE INTEGRA MATRIX WOUND DRESSING (IMWD) WERE REMOVED DURING THE SECOND PROCEDURE IN ORDER TO PROVIDE SURGICAL ACCESS TO STOP THE BLEEDING. IMWD WERE NOT REPLACED DURING THE SECOND SURGERY. THE PT DIED THREE DAYS LATER. THERE WAS NO REPORT THAT THE PT'S OUTCOME WAS RELATED TO USE OF THE DEVICE. INTEGRA MATRIX WOUND DRESSING PACKAGE INSERT DOES NOT STATE THAT IT IS INDICATED FOR USE WITH NEGATIVE PRESSURE WOUND MANAGEMENT SYSTEMS. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFO FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA MATRIX WOUND DRESSING 2X2 SINGLE DOMESTIC NA KGN INTEGRA LIFESCIENCES CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention