BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIV.A.C.® THERAPY

    MDR report key: 5086139 · Received September 17, 2015

    Report

    Report Number
    3009897021-2015-00069
    Event Type
    Injury
    Date Received
    September 17, 2015
    Report Date
    September 17, 2015
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHEN THE EVENT OCCURRED AS THIS INFORMATION HAS NOT BEEN PROVIDED. BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED MACERATION IS RELATED TO V.A.C.® THERAPY. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: ENSURING DRESSING INTEGRITY: IT IS RECOMMENDED THAT A CLINICIAN OR PATIENT (IN THE HOME) VISUALLY CHECK THE DRESSING EVERY TWO HOURS TO ENSURE THAT THE FOAM IS FIRM AND COLLAPSED IN THE WOUND BED WHILE THERAPY IS ACTIVE IF NOT: IDENTIFY AIR LEAKS BY LISTENING WITH A STETHOSCOPE OR MOVING YOUR HAND AROUND THE EDGES OF THE DRESSING WHILE APPLYING LIGHT PRESSURE. IF A LEAK SOURCE IS IDENTIFIED, PATCH WITH ADDITIONAL DRAPE TO ENSURE SEAL INTEGRITY. CAUTION: USE AS FEW LAYERS OF DRAPE AS POSSIBLE. MULTIPLE LAYERS OF THE V.A.C.® DRAPE MAY DECREASE THE MOISTURE VAPOR TRANSMISSION RATE, WHICH MAY INCREASE THE RISK OF MACERATION, ESPECIALLY IN SMALL WOUNDS, LOWER EXTREMITIES OR LOAD-BEARING AREAS. MAINTAINING A SEAL: FOR DELICATE PERIWOUND TISSUE OR IN AREAS THAT ARE DIFFICULT TO DRESS, APPLY PROTECTIVE SKIN PREPARATION AND FRAME THE WOUND WITH TRANSPARENT FILM OR HYDROCOLLOID DRESSING OR OTHER APPROPRIATE BARRIER. POSITION THE DRESSING TUBING ON FLAT SURFACES AND AWAY FROM THE PERINEAL AREA, BONY PROMINENCES OR PRESSURE AREAS. FOOT WOUNDS: FOR WOUNDS ON THE PLANTAR SURFACE OR HEEL OF THE FOOT, IT IS BEST TO USE A BRIDGING TECHNIQUE TO ENSURE THAT ADDITIONAL PRESSURE IS NOT APPLIED AS A CONSEQUENCE OF PLACEMENT OF THE TUBING AND/OR SENSAT.R.A.C/T.R.A.C. PAD. THIS INVOLVES USING THE FOAM TO ALLOW PLACEMENT OF THE SENSAT.R.A.C./T.R.A.C PAD OR TUBING ON THE DORSUM OF THE FOOT (CONSIDER USE OF THE V.A.C.® GRANUFOAMHEEL DRESSING).

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE PATIENT EXPERIENCED A TECHNICAL ISSUE WITH V.A.C. THERAPY AND ALLEGED OBSERVING MACERATION TO THE PATIENT'S WOUND. ON (B)(6) 2015, KCI RECEIVED PATIENT MEDICAL RECORDS THAT STATED THE FOLLOWING: THE PATIENT UNDERWENT SHARP DEBRIDEMENT ALONG WITH AN INCREASE IN V.A.C. THERAPY PRESSURE. DATE OF DEBRIDEMENT NOT PROVIDED. THE PATIENT CONTINUED TO RECEIVE V.A.C. THERAPY AND IS "STABLE WITH WOUND IMPROVEMENT NOTED." ON (B)(6) 2015, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI QUALITY ENGINEERING, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2014, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616577 ACTIV.A.C.® THERAPY ACTIV.A.C.® OMP KCI USA, INC. WNDACT

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention