BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIV.A.C.® THERAPY

    MDR report key: 6202837 · Received December 23, 2016

    Report

    Report Number
    3009897021-2016-00119
    Event Type
    Injury
    Date Received
    December 23, 2016
    Date of Event
    November 27, 2016
    Report Date
    May 11, 2017
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE ADDITIONAL INFORMATION OBTAINED REGARDING THE DEVICE, KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED THAT THE ALLEGED INFECTION IS RELATED TO V.A.C.® THERAPY.

    Additional Manufacturer Narrative · 1

    BASED ON THE ADDITIONAL INFORMATION OBTAINED REGARDING THE DISPOSABLES, KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED THAT THE ALLEGED INFECTION IS RELATED TO V.A.C.® THERAPY.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED PAIN AND HOSPITALIZATION FOR AN INFECTED WOUND ABSCESS ARE RELATED TO THE USE OF THE ACTIV.A.C. THERAPY. THERE HAVE BEEN MULTIPLE ATTEMPTS MADE TO GATHER ADDITIONAL INFORMATION, BUT THERE HAS BEEN NO RESPONSE. DEVICE LABELING, AVAILABLE IN PRINT STATES: DRESSING CHANGES: WOUNDS BEING TREATED WITH THE V.A.C. THERAPY SYSTEM SHOULD BE MONITORED ON A REGULAR BASIS. IN A MONITORED, NON-INFECTED WOUND, V.A.C. DRESSINGS SHOULD BE CHANGED EVERY 48-72 HOURS, BUT NO LESS THAN 3 TIMES A WEEK, WITH FREQUENCY ADJUSTED BY THE CLINICIAN AS APPROPRIATE. INFECTED WOUNDS MUST BE MONITORED OFTEN AND VERY CLOSELY. FOR THESE WOUNDS, DRESSINGS MAY NEED TO BE CHANGED MORE OFTEN THAN 48-72 HOURS; THE DRESSING CHANGING INTERVALS SHOULD BE BASED ON A CONTINUING EVALUATION OF THE WOUND CONDITION AND THE PATIENT'S CLINICAL PRESENTATION, RATHER THAN A FIXED SCHEDULE. INFECTION: INFECTED WOUNDS SHOULD BE MONITORED CLOSELY AND MAY REQUIRE MORE FREQUENT DRESSING CHANGES THAN NON-INFECTED WOUNDS, DEPENDENT UPON FACTORS SUCH AS WOUND CONDITIONS, TREATMENT GOALS AND INSTILLATION THERAPY PARAMETERS (FOR THE V.A.C. INSTILL THERAPY SYSTEM). REFER TO DRESSING APPLICATION INSTRUCTIONS (FOUND IN V.A.C. DRESSING CARTONS) FOR DETAILS REGARDING DRESSING CHANGE FREQUENCY. AS WITH ANY WOUND TREATMENT, CLINICIANS AND PATIENTS/CAREGIVERS SHOULD FREQUENTLY MONITOR THE PATIENT'S WOUND, PERIWOUND TISSUE AND EXUDATE FOR SIGNS OF INFECTION, WORSENING INFECTION, OR OTHER COMPLICATIONS. SOME SIGNS OF INFECTION ARE FEVER, TENDERNESS, REDNESS, SWELLING, ITCHING, RASH, INCREASED WARMTH IN THE WOUND OR PERIWOUND AREA, PURULENT DISCHARGE OR STRONG ODOR. INFECTION CAN BE SERIOUS, AND CAN LEAD TO COMPLICATIONS SUCH AS PAIN, DISCOMFORT, FEVER, GANGRENE, TOXIC SHOCK, SEPTIC SHOCK AND/OR FATAL INJURY. SOME SIGNS OR COMPLICATIONS OF SYSTEMIC INFECTION ARE NAUSEA, VOMITING, DIARRHEA, HEADACHE, DIZZINESS, FAINTING, SORE THROAT WITH SWELLING OF THE MUCUS MEMBRANES, DISORIENTATION, HIGH FEVER, REFRACTORY AND/OR ORTHOSTATIC HYPOTENSION OR ERYTHRODERMA (A SUNBURN-LIKE RASH). IF THERE ARE ANY SIGNS OF THE ONSET OF SYSTEMIC INFECTION OR ADVANCING INFECTION AT THE WOUND SITE, CONTACT THE TREATING PHYSICIAN IMMEDIATELY TO DETERMINE IF V.A.C. THERAPY SHOULD BE DISCONTINUED. PAIN MANAGEMENT: PATIENTS RECEIVING V.A.C. THERAPY MAY EXPERIENCE A REDUCTION IN PAIN AS THE WOUND BEGINS TO HEAL. HOWEVER, SOME PATIENTS EXPERIENCE DISCOMFORT DURING TREATMENT OR DRESSING CHANGES. IN LINE WITH INSTITUTIONAL GUIDELINES, A VALIDATED PAIN SCORING TOOL SHOULD BE USED AND PAIN SCORES SHOULD BE DISCONTINUED WHERE APPROPRIATE BEFORE, DURING AND AFTER DRESSING-RELATED PROCEDURES. IN ADDITION, THE FOLLOWING STRATEGIES SHOULD BE CONSIDERED: -IF THE PATIENT COMPLAINS OF DISCOMFORT THROUGHOUT THERAPY, CONSIDER CHANGING TO V.A.C. WHITEFOAM DRESSING. -ENSURE THE PATIENT RECEIVES ADEQUATE ANALGESIA DURING TREATMENT. -IF THE PATIENT COMPLAINS OF DISCOMFORT DURING THE DRESSING CHANGE, CONSIDER PREMEDICATION, THE USE OF A NON-ADHERENT LAYER BEFORE FOAM PLACEMENT, USING V.A.C. WHITEFOAM TO DRESS THE WOUND, OR MANAGING THE DISCOMFORT AS PRESCRIBED BY THE TREATING PHYSICIAN. -A SUDDEN INCREASE OR CHANGE IN THE CHARACTER OF THE PAIN REQUIRES INVESTIGATION.

    Description of Event or Problem · 1

    A REVIEW OF KCI SERVICE RECORDS BY QUALITY ENGINEERING COMPLETED ON MAY 01 2017 FOUND THE FOLLOWING: ON (B)(6) 2016, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI FIELD SERVICE AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS PRIOR TO THE PATIENT PLACEMENT ON (B)(6) 2016. THE DEVICE WAS RETURNED TO A KCI SERVICE CENTER ON FEB 08 2017, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE, PASSED AND WAS PLACED ON A SUBSEQUENT PATIENT. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

    Description of Event or Problem · 1

    KCI COMPLETED A MANUFACTURING RECORDS REVIEW FOR V.A.C.® GRANUFOAM¿ LOT NO. 2929895. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS.

    Description of Event or Problem · 1

    ON NOV 27 2016, THE FOLLOWING INFORMATION WAS RECEIVED BY KCI FROM THE PATIENT: THE PATIENT ALLEGED SHE WAS GOING TO THE EMERGENCY ROOM (ER) AS SHE WAS HAVING "GREAT" PAIN AND THERE WERE CHANGES IN THE CHARACTER OF HER WOUND. ON NOV 28 2016, THE FOLLOWING INFORMATION WAS RECEIVED BY KCI FROM THE NURSE: THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER GOING TO THE ER FOR THE REPORTED PAIN. ON NOV 28 2016, THE FOLLOWING INFORMATION WAS RECEIVED BY KCI FROM THE CERTIFIED NURSING ASSISTANT: THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR PAIN AND AN INFECTED ABDOMINAL ABSCESS. NO ADDITIONAL INFORMATION COULD BE PROVIDED. ON NOV 10 2016, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI FIELD SERVICE, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. ON NOV 29 2016, KCI QUALITY ENGINEERING ATTEMPTED TO RETRIEVE THE DEVICE, BUT PATIENT REFUSED TO ALLOW AN EXCHANGE. AS OF THE DATE OF THIS REPORT THE UNIT REMAINS WITH THE PATIENT. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853243 ACTIV.A.C.® THERAPY OMP OMP KCI USA, INC. WNDAAI 2929895

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| O