BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVENA¿ INCISION MANAGEMENT SYSTEM

    MDR report key: 7686789 · Received July 13, 2018

    Report

    Report Number
    3009897021-2018-00065
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    January 1, 2012
    Report Date
    July 13, 2018
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    PMA / PMN Number
    K100821
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED INFECTIONS ARE RELATED TO THE PREVENA¿ INCISION MANAGEMENT SYSTEM. IT IS UNKNOWN WHAT MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED. THE ARTICLE NOTED, "SURGICAL SITE INFECTIONS IN THE GROIN POSE A MAJOR PROBLEM IN VASCULAR SURGERY WITH AN INCIDENCE AFTER VASCULAR PROCEDURES OF 6-30%." NO ADDITIONAL INFORMATION IS AVAILABLE. THE PREVENA¿ INCISION MANAGEMENT SYSTEM WILL NOT BE EFFECTIVE IN ADDRESSING COMPLICATIONS ASSOCIATED WITH THE FOLLOWING: UNTREATED OR INADEQUATELY TREATED INFECTION, CELLULITIS OF THE INCISION AREA.

    Description of Event or Problem · 1

    ON JUN 15 2018, THE FOLLOWING INFORMATION WAS RECEIVED BY KCI AFTER A REVIEW OF JOURNAL ARTICLE, ENGELHARDT, MICHAEL ET AL. "CLOSED-INCISION NEGATIVE PRESSURE THERAPY TO REDUCE GROIN WOUND INFECTIONS IN VASCULAR SURGERY: A RANDOMIZED CONTROLLED TRIAL" INTERNATIONAL WOUND JOURNAL, (2018); DOI: 10.111/IWJ.12848: AT THE FIFTH POSTOPERATIVE DAY SSIS [SURGICAL SITE INFECTIONS] WERE OBSERVED IN 4 OUT OF 64 PATIENTS IN THE CINPT GROUP. IT WAS NOTED THAT IN THE CINPT GROUP, I AND II GRADE INFECTIONS WERE OBSERVED. NO PATIENT DEVELOPED A SEVERE SSI III. THE CINPT DRESSING WAS REMOVED AFTER 5 DAYS. GRADE I INFECTIONS ONLY INVOLVED THE SKIN (DERMAL INFECTION), GRADE II EXTENDED TO THE SUBCUTANEOUS TISSUE WITHOUT REACHING THE VESSELS, AND GRADE III FINALLY INVOLVED THE ARTERY OR BYPASS. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER OF THE DEVICES USED WERE NOT INCLUDED, THUS A DEVICE EVALUATION CANNOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526596 PREVENA¿ INCISION MANAGEMENT SYSTEM OMP OMP KINETIC CONCEPTS, INC. WNDPRV NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other