BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVENA INCISION MANAGEMENT SYSTEM

    MDR report key: 2210533 · Received August 10, 2011

    Report

    Report Number
    1625774-2011-00099
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K100821
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES THE PREVENA INCISION MANAGEMENT SYSTEM SHOULD NOT BE USED TO TREAT OPEN OR DEHISCED SURGICAL WOUNDS OR ON PATIENTS WHO HAVE EXCESSIVE AMOUNTS OF EXUDATE FROM THE INCISION AREA WHICH MAY EXCEED THE PREVENA 45ML CANISTER.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE WOUND CARE NURSE: THE PATIENT HAD A HIGH RISK ABDOMINAL INCISION LINE. THE KCI PREVENA INCISION MANAGEMENT SYSTEM WAS PRESCRIBED BY THE TREATING HEALTHCARE PROVIDER POST SURGERY. IT WAS REPORTED THAT PREVENA UNIT WAS REPLACED DUE TO ALARMING ISSUES THROUGHOUT THE NIGHT. THE REASON FOR THE ALARMING ISSUES WAS NOT PROVIDED BY THE REPORTER. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2011, THE WOUND CARE NURSE REPORTED THAT THE TREATING HEALTHCARE PROVIDER ORDERED A CHANGE TO A VAC THERAPY SYSTEM DUE TO THE TYPE OF INCISION THAT THE PATIENT HAD. THE NURSE STATED THAT THE PREVENA THERAPY SYSTEM MAY NOT HAVE BEEN THE RIGHT CHOICE OF THERAPY FOR THE PATIENT. THE CLOSED INCISION HAD TO BE RE-OPENED AND DEBRIDED DUE TO INFECTION. ALTHOUGH THERE WAS NO DETERMINATION THAT THERAPIES PRESCRIBED MAY HAVE CAUSED OR CONTRIBUTED, BASED ON THE INFORMATION PROVIDED THIS REPORT IS BEING FILED AS POSSIBLE USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREVENA INCISION MANAGEMENT SYSTEM OMP KCI USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention