BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIV.A.C.® THERAPY

    MDR report key: 5018171 · Received August 20, 2015

    Report

    Report Number
    3009897021-2015-00059
    Event Type
    Injury
    Date Received
    August 20, 2015
    Date of Event
    July 20, 2015
    Report Date
    August 27, 2015
    Manufacturer
    KCI USA,INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE ADDITIONAL INFORMATION OBTAINED REGARDING THE DRESSING, KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED THAT THE ALLEGED WOUND DETERIORATION AND HOSPITALIZATION ARE RELATED TO V.A.C.® THERAPY.

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED WOUND DETERIORATION AND HOSPITALIZATION ARE RELATED TO V.A.C. THERAPY. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO GATHER ADDITIONAL INFORMATION, BUT THERE HAS BEEN NO RESPONSE. IT IS UNKNOWN WHAT MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED AS THIS INFORMATION HAS NOT BEEN PROVIDED. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: IF A WOUND HAS BEEN PROGRESSING WELL FROM DRESSING CHANGE TO DRESSING CHANGE BUT THEN DETERIORATES RAPIDLY, CONSIDER THE FOLLOWING INTERVENTIONS AND, WHERE NECESSARY, SEEK THE GUIDANCE/EXPERTISE OF A SPECIALIST: CHECK THE THERAPY HOUR METER TO ENSURE THAT THE ACTUAL NUMBER OF THERAPY HOURS RECEIVED MATCHES THE NUMBER OF RECOMMENDED THERAPY HOURS (22 HOURS A DAY). IF THE NUMBER OF THERAPY HOURS IS LESS THAN 22 EACH DAY, FIND OUT WHY THERE IS A THERAPY DEFICIT AND REMEDY THE SITUATION. CLEAN WOUND MORE THOROUGHLY DURING DRESSING CHANGES. EVALUATE FOR SIGNS AND SYMPTOMS OF INFECTION AND, IF PRESENT, TREAT ACCORDINGLY. CHANGE DRESSING OFTEN, ENSURING THAT IT IS BEING CHANGED AT LEAST EVERY 48 HOURS. EXAMINE THE WOUND AND DEBRIDE AS NECESSARY. DEBRIDE THE WOUND EDGES IF THEY APPEAR NON-VIABLE OR ROLLED UNDER AS THIS MAY INHIBIT THE FORMATION OF GRANULATION TISSUE AND MIGRATION OF EPITHELIAL CELLS OVER AN ACCEPTABLE WOUND BASE.

    Description of Event or Problem · 1

    ON AUG 26 2015, A DEVICE HISTORY REVIEW OF THE V.A.C. GRANUFOAM DRESSING (LOT NUMBER 2631875) WAS PERFORMED BY KCI QUALITY ENGINEERING WHO DETERMINED THE FOLLOWING: ALL END RELEASE TESTING OF PRODUCT AND PACKAGING PERFORMANCE MET THE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO KCI: THE PATIENT WAS ADMITTED TO THE HOSPITAL ALLEGEDLY DUE TO THE ACTIV. A.C. DEVICE "STOPPED WORKING," AND THE PATIENT'S WOUND DETERIORATED. ON (B)(6) 2015, THE FOLLOWING INFORMATION WAS REPORTED TO KCI: THE PATIENT EXPERIENCED A TECHNICAL ISSUE WITH ACTIV. A.C. THERAPY. THE PATIENT'S "WOUND WORSENED, PATIENT FELT COMPELLED TO GO THE EMERGENCY ROOM AND WAS ADMITTED." NO ADDITIONAL INFORMATION IS AVAILABLE. ON JUL 16 2015, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI FIELD SERVICE, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2015, THE DEVICE WAS PLACED WITH THE PATIENT. ON AUG 05 2015, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI QUALITY ENGINEERING, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT. A DEVICE HISTORY REVIEW OF THE V.A.C. GRANUFOAM DRESSING (LOT NUMBER 2631875) IS PENDING COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550835 ACTIV.A.C.® THERAPY OMP OMP KCI USA,INC. WNDACT 2631875

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R