BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. ATS

    MDR report key: 3940140 · Received June 19, 2014

    Report

    Report Number
    3009897021-2014-00073
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    October 27, 2010
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    PMA / PMN Number
    K062227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THIS EVENT OCCURRED IN 2010, AND THE EXACT DATE HAS NOT BEEN PROVIDED. THE PHYSICIAN REPORTED THAT "IT SHOULD BE WAITED UNTIL THE NEXT DAY," AFTER THE DEBRIDEMENT TO APPLY V.A.C. THERAPY. "IT WAS CONSIDERED THAT INAPPROPRIATE USE OF V.A.C. THERAPY, THEREFORE, THESE ADVERSE EVENTS OCCURRED. RIGHT AFTER SURGERY, V.A.C. THERAPY USED INAPPROPRIATELY." IT WAS REPORTED THAT THE WOUND WAS TREATED WITH IRRIGATION, AN APPLICATION OF AN OINTMENT, AND POVIDONE-IODINE SUGAR GAUZE. BASED ON INFO PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED HEMATOMA, HEMORRHAGING, OR NECROSIS IS RELATED TO V.A.C. THERAPY. IT IS UNK IF SURGICAL INTERVENTION WAS PERFORMED FOR THE EITHER THE NECROTIC TISSUE OR BLEEDING FROM THE BONE MARROW/BLOOD VESSEL. THIS REPORT IS BEING FILED DUE TO POSSIBLE USER ERROR. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED TO KCI BY THE (B)(4) REP: THE PHYSICIAN STATED THE PT RECEIVED A LEFT METATARSAL EXCISION AND DEBRIDEMENT DUE TO TRAUMA. THE 10CMX2CM WOUND WAS LOCATED ON THE OUTER LEFT FOOT, AND THE WOUND DEPTH REACHED THE METATARSAL. IT WAS NOTED THAT "ALTHOUGH EXPOSURE OF BONE MARROW, HEMOSTASIS OBSERVED," AND V.A.C. THERAPY WAS APPLIED. THE NEXT DAY, APPROX 200CC OF BLOOD WAS ALLEGEDLY OBSERVED IN THE CANISTER, AND A HEMATOMA "PROTRUDED" FROM THE DRESSING. A DEBRIDEMENT WAS PERFORMED, AND V.A.C. THERAPY WAS RE-APPLIED. THE FOLLOWING DAY, 300CC OF BLOOD WAS NOTED IN THE CANISTER, AND WOUND NECROSIS WAS OBSERVED. V.A.C. THERAPY WAS DISCONTINUED. THE BLEEDING WAS DETERMINED TO BE FROM THE BONE MARROW AND FROM A "TINY" BLOOD VESSEL FROM SUBCUTANEOUS TISSUE. AFTER V.A.C. THERAPY WAS DISCONTINUED, "IRRIGATION, AN OINTMENT SUCH AS ETHACRIDINE LACTATE AND POVIDONE-IODINE SUGAR GAUZE WERE APPLIED." IT WAS NOTED THAT "THE WOUND SURFACE WAS STILL NECROTIZED AND NOT IMPROVED. DATES NOT PROVIDED. THE UNIT'S SERIAL NUMBER WAS NOT PROVIDED, THEREFORE, KCI CANNOT CONDUCT A DEVICE EVAL OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359693 V.A.C. ATS OMP KCI USA INC. WNDATS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention