BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. GRANUFOAM SILVER® DRESSING

    MDR report key: 6121528 · Received November 22, 2016

    Report

    Report Number
    3009897021-2016-00100
    Event Type
    Injury
    Date Received
    November 22, 2016
    Date of Event
    October 31, 2016
    Report Date
    November 22, 2016
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K050261
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, THE FOREIGN MATERIAL ALLEGED TO BE V.A.C. GRANUFOAM SILVER® 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. ADDITIONAL PRECAUTIONS FOR V.A.C. GRANUFOAM SILVER® DRESSING PROTECTIVE LAYER: FOR MAXIMUM EFFECTIVENESS, THE V.A.C. GRANUFOAM SILVER® DRESSING SHOULD BE APPLIED DIRECTLY TO THE WOUND SURFACE TO ENHANCE OPTIMAL CONTACT OF THE TISSUE WITH THE FOAM/SILVER INTERFACE. HOWEVER, AS WITH ALL V.A.C.® FOAM DRESSINGS, THE V.A.C. GRANUFOAM SILVER® DRESSING SHOULD NOT BE PLACED IN DIRECT CONTACT WITH EXPOSED BLOOD VESSELS, ANASTOMOTIC SITES, ORGANS OR NERVES (REFER TO SECTION ON PROTECT VESSELS AND ORGANS). INTERVENING NON-ADHERENT LAYERS MAY BE PLACED BETWEEN THE V.A.C. GRANUFOAM SILVER® DRESSING AND THE WOUND SURFACE; HOWEVER, THESE PRODUCTS MAY COMPROMISE THE EFFECTIVENESS OF THE V.A.C. GRANUFOAM SILVER® DRESSING IN THE AREA COVERED BY THE NON-ADHERENT LAYER. NO DEVICE IDENTIFIER PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE NURSE ALLEGED EXPERIENCING DIFFICULTY REMOVING THE DRESSING AND STATED, "SHE IS TAKING OFF SOME MUSCLE..." ON (B)(6) 2016, KCI GLOBAL SAFETY REPRESENTATIVE SPOKE TO THE NURSE WHO REPORTED THE FOREIGN MATERIAL, ALLEGED TO BE V.A.C.® FOAM DRESSING, WAS ADHERING TO THE WOUND, AND A 30 MINUTE SALINE SOAK WAS UNSUCCESSFUL. ON NOV 02 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE V.A.C. GRANUFOAM SILVER® DRESSING WAS ADHERING AND ATTEMPTING TO REMOVE THE DRESSING PULLED ON THE MUSCLE UNDERNEATH. THE PATIENT WENT TO THE EMERGENCY ROOM AND UNDERWENT SHARP DEBRIDEMENT TO REMOVE THE ADHERED DRESSING. THE NURSE STATED THE DRESSING WAS PLACED IN OPERATING ROOM, AND THE PHYSICIAN REFUSED TO USE A NON ADHERENT DRESSING PRIOR TO PLACING THE V.A.C. GRANUFOAM SILVER® DRESSING DIRECTLY ON TOP OF MUSCLE. THE WOUND IS REPORTEDLY LOOKING GOOD AND, THE PATIENT IS CURRENTLY ON AN ALTERNATE THERAPY. THE V.A.C. GRANUFOAM SILVER® DRESSING LOT NUMBER IS NOT AVAILABLE; THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774118 V.A.C. GRANUFOAM SILVER® DRESSING OMP OMP KCI USA, INC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention