BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. ® GRANUFOAM¿ DRESSING

    MDR report key: 6202853 · Received December 23, 2016

    Report

    Report Number
    3009897021-2016-00118
    Event Type
    Injury
    Date Received
    December 23, 2016
    Date of Event
    November 6, 2016
    Report Date
    December 23, 2016
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, THE FOREIGN MATERIAL ALLEGED TO BE V.A.C. GRANUFOAM DRESSING WAS NOT RETURNED TO KCI FOR IDENTIFICATION; THEREFORE, KCI IS UNABLE TO CONFIRM ITS IDENTITY. KCI IS SUBMITTING AS A POTENTIAL USER ERROR AS DRESSING CHANGES DID NOT OCCUR AS RECOMMENDED. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, 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. FOAM REMOVAL: V.A.C. FOAM DRESSINGS ARE NOT BIOABSORBABLE. ALWAYS COUNT THE TOTAL NUMBER OF PIECES OF FOAM REMOVED FROM THE WOUND AND ENSURE THE SAME NUMBER OF FOAM PIECES ARE REMOVED AS WERE PLACED. FOAM LEFT IN THE WOUND FOR GREATER THAT THE RECOMMENDED TIME PERIOD MAY FOSTER INGROWTH OF TISSUE INTO THE FOAM, CREATE DIFFICULTY IN REMOVING THE FOAM FROM THE WOUND OR LEAD TO INFECTION OR OTHER ADVERSE EVENTS. IF DRESSING ADHERES TO WOUND CONSIDER INTRODUCING STERILE WATER OR NORMAL SALINE INTO THE DRESSING, WAITING 15 - 30 MINUTES, THEN GENTLY REMOVING THE DRESSING FROM THE WOUND. REGARDLESS OF TREATMENT MODALITY, DISRUPTION OF THE NEW GRANULATION TISSUE DURING ANY DRESSING CHANGE MAY RESULT IN BLEEDING AT THE WOUND SITE. MINOR BLEEDING MAY BE OBSERVED AND CONSIDERED EXPECTED. HOWEVER, PATIENTS WITH INCREASED RISK OF BLEEDING, AS DESCRIBED ON PAGE 8, HAVE A POTENTIAL FOR MORE SERIOUS BLEEDING FROM THE WOUND SITE. AS A PRECAUTIONARY STEP, CONSIDER USING V.A.C. WHITEFOAM OR NON-ADHERENT MATERIAL UNDERNEATH THE V.A.C. GRANUFOAM DRESSING TO HELP MINIMIZE THE POTENTIAL FOR BLEEDING AT DRESSING REMOVAL IN THESE PATIENTS. 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. NO DEVICE IDENTIFIER PROVIDED.

    Description of Event or Problem · 1

    ON NOV 25 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT'S FAMILY MEMBER: THE PATIENT WAS ALLEGEDLY IN THE HOSPITAL AWAITING FOR DISCHARGE TO GO HOME. ON NOV 28 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE PATIENT WAS ADMITTED TO THEIR SERVICES ON (B)(6) 2016 AFTER DISCHARGE FROM THE HOSPITAL. THE V.A.C. THERAPY DRESSING HAD BEEN PLACED BY THE DISCHARGING FACILITY SO THE DRESSING WAS NOT CHANGED DURING THE ADMISSION. ON (B)(6) 2016 THE PATIENT SAW THE PHYSICIAN. THE PHYSICIAN ASSESSED THE WOUND AND FOUND THAT THERE WAS ADHERED GRANUFOAM IN THE WOUND. A SHARP DEBRIDEMENT WAS DONE TO REMOVE THE FOAM. ON (B)(6) 2016, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO AN INFECTION AND WORSENING OF THE WOUND. THE PATIENT HAS NOT BEEN RETURNED TO THEIR SERVICES AT THIS TIME. ON (B)(6) 2016, THE PATIENT'S DAUGHTER PROVIDED AN UPDATE ON THE PATIENT'S CONDITION STATING THE PATIENT WAS IMPROVING SINCE HOSPITAL ADMISSION AND WITH TREATMENT OF ANTIBIOTICS. SHE COULD NOT PROVIDE ANY LOT NUMBERS FOR THE GRANUFOAM DRESSING . THE DRESSING WAS APPLIED BY THE DISCHARGING HOSPITAL WHO DID NOT PROVIDE ANY LOT NUMBERS. THE FOAM WAS DISCARDED AND NOT AVAILABLE FOR RETURN. THE V.A.C. GRANUFOAM DRESSING LOT NUMBER WAS NOT PROVIDED AND IT WAS CONFIRMED THAT THE DRESSING HAD BEEN DISCARDED. THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852624 V.A.C. ® GRANUFOAM¿ DRESSING OMP OMP KCI USA, INC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R