BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 2010934 · Received March 4, 2011

    Report

    Report Number
    1625774-2011-00028
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    January 25, 2011
    Report Date
    February 10, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K06227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT PASSED QUALITY CONTROL CHECKS AND MET SPECIFICATIONS PRIOR TO AND AFTER PLACEMENT WITH THE PT. THERE WAS NO EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE DEVICE DURING THE QC INSPECTIONS. THE V.A.C. GRANUFOAM WAS NOT RETURNED FOR EVAL. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES VAC FOAM DRESSINGS ARE NOT BIOABSORBABLE. FOAM LEFT IN THE WOUND FOR GREATER THAN THE RECOMMENDED TIME PERIOD MAY FOSTER IN-GROWTH OF TISSUE INTO THE FOAM AND CREATE DIFFICULTY IN REMOVING FOAM FROM THE WOUND OR LEAD TO INFECTION OR OTHER ADVERSE EVENTS.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED TO KCI BY THE PT: ON (B)(6) 2011, THE PT REPORTED VIA TELEPHONE THAT ACTIV.A.C. THERAPY CAUSED AN INFECTION. ADDITIONAL INFO ON (B)(6) 2011, THE DOCTOR REPORTED THAT THE PT WAS STARTED ON ACTIVAC THERAPY ON (B)(6) 2011 FOR PROMOTION OF GRANULATION TISSUE FORMATION. ACCORDING TO THE HEALTHCARE PROVIDERS, THE PT HAD BEEN VERY NON-COMPLIANT, NOT SHOWING UP FOR DRESSING CHANGES OR APPOINTMENTS AND ON (B)(6)2011 THE PT HAD TO HAVE ADHERED V.A.C. GRANUFOAM DRESSING REMOVED FROM THE WOUND SURGICALLY UNDER LOCAL ANESTHESIA AT THE OFFICE DUE TO MISSING DRESSING CHANGES AND ALLOWING GRANULATION TISSUE GROWTH INTO THE V.A.C. GRANUFOAM. IT WAS ORIGINALLY REPORTED THAT THE PT MAY HAVE EXPERIENCED SIGNS OF INFECTION BUT IT WAS LATER CLARIFIED BY THE DOCTOR THAT THE PT HAD NOT HAD ANY WOUND INFECTIONS AS A RESULT OF THE REPORTED NON-COMPLIANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V.A.C. THERAPY SYSTEM OMP KCI USA, INC. V.A.C. GRANUFOAM

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention