BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 3940131 · Received June 19, 2014

    Report

    Report Number
    3009897021-2014-00077
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    May 22, 2014
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S INCLUDED IN THIS STUDY WERE TREATED WITH NEGATIVE PRESSURE WOUND THERAPY FROM (B)(6) 2006 TO (B)(6) 2008. IT IS UNK WHEN THE EVENTS OCCURRED AS THIS INFO HAS NOT BEEN PROVIDED. BASED ON INFO PROVIDED, IT CANNOT BE DETERMINE THAT THE ALLEGED HEMATOMA IS RELATED TO V.A.C THERAPY. THE ARTICLE STATED, "THIS PT WITH THROMBOEMBOLIC DISEASE WAS FULLY ANTICOAGULATED WITH HEPARIN AND THE V.A.C WAS USED FOR LOWER EXTREMITY WOUND FOLLOWING COMPARTMENT RELEASE." THEREFORE, THE PT WAS PRONE TO BLEEDING AND WOULD EXPERIENCE DIFFICULTY ARRESTING A HEMORRHAGE. IT IS UNK IF MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED FOR THE HEMATOMA. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO GATHER ADDITIONAL INFO, BUT THERE HAS BEEN NO RESPONSE.

    Description of Event or Problem · 1

    KCI RECEIVED ARTICLE, DORAFSHAR, AMIR H., MIECZYSLAWA, FRANCZYK, GOTTLIEB, LAWRENCE J., WROBLEWSKI, KRISTEN E., LOHMAN, ROBERT F A PROSPECTIVE RANDOMIZED TRAIL COMPARING SUBATMOSPHERIC WOUND THERAPY WITH A SEALED GAUZE DRESSING AND THE STANDARD VACUUM-ASSISTED CLOSURE DEVICE, ANNALS OF PLASTIC SURGERY. A 69 (1): 79-84, JULY 2012. DOI:10.1097/SAP.0B013E318221286C THAT REPORTED A PT WITH A LOWER EXTREMITY WOUND POST OPERATIVE FASCIOTOMY WAS PLACED ON V.A.C. THERAPY. V.A.C THERAPY WAS DISCONTINUED AFTER 5 DAYS ALLEGEDLY DUE TO THE DEVELOPMENT OF A HEMATOMA. NO ADDITIONAL INFO IS AVAILABLE. THE UNIT'S TYPE OR SERIAL NUMBER WAS NOT PROVIDED, THEREFORE KCI CANNOT CONDUCT A DEVICE EVALUATION OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359690 V.A.C. THERAPY OMP KCI USA INC. WNDVAC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HEPARIN (DOSAGE UNK)