BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. ® GRANUFOAM¿ DRESSING

    MDR report key: 6179436 · Received December 15, 2016

    Report

    Report Number
    3009897021-2016-00110
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 16, 2016
    Report Date
    December 15, 2016
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. 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. DEVICE IDENTIFIER NOT PROVIDED.

    Description of Event or Problem · 1

    ON NOV 17 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE KCI REPRESENTATIVE: THE WOUND CARE CENTER ALLEGED THAT THE "BLACK SPONGE" WAS STUCK IN THE PATIENT'S WOUND AND THEY ATTEMPTED TO REMOVE WITH A SHARP DEBRIDEMENT, BUT WERE NOT COMPLETELY SUCCESSFUL IN REMOVING ALL OF THE FOAM. THE PATIENT WAS SCHEDULED FOR A FOLLOW-UP APPOINTMENT TO ATTEMPT COMPLETION OF REMOVAL OF THE REST OF THE FOAM. THE PHYSICIAN ORDERED AN ALTERNATE DRESSING WITH THE USE OF ALGINATE TO PLACE IN THE WOUND TO ASSIST IN COMPLETION OF THE FOAM REMOVAL. ON (B)(6) 2016, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE WOUND CARE CENTER NURSE: AN INITIAL SHARP DEBRIDMENT WAS COMPLETED TO REMOVE THE ADHERED "SPONGE," BUT THEY WERE UNSUCCESSFUL IN REMOVING ALL FOAM BECAUSE THE PATIENT WAS UNABLE TO TOLERATE THE ENTIRE PROCEDURE. THE PATIENT WAS SCHEDULED FOR A SECOND DEBRIDEMENT PROCEDURE IN TWO WEEKS TO HAVE THE REST OF THE "SPONGE" REMOVED. ON DEC 15 2016, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE WOUND CARE CENTER NURSE: THE INITIAL DEBRIDEMENT TOOK PLACE ON (B)(6) 2016 AND THE PATIENT HAD A FOLLOW-UP DEBRIDEMENT COMPLETED ON (B)(6) 2016. THE WOUND CARE CLINIC DID NOT PROVIDE THE V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER AND CONFIRMED IT WAS NOT AVAILABLE FOR RETURN, THEREFORE A DEVICE HISTORY REVIEW AND A DEVICE EVALUATION COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827581 V.A.C. ® GRANUFOAM¿ DRESSING OMP OMP KCI USA, INC. WNDACT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention