BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. WHITEFOAM¿ DRESSING

    MDR report key: 19173015 · Received April 24, 2024

    Report

    Report Number
    3009897021-2024-00025
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    March 15, 2024
    Report Date
    April 24, 2024
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    PMA / PMN Number
    K133276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, IT COULD NOT BE DETERMINED THAT THE ALLEGED ALLERGIC REACTION IS RELATED TO THE V.A.C. WHITEFOAM¿ DRESSING. SUREPREP SPRAY WAS APPLIED TO PERIWOUND PRIOR TO V.A.C.® DRAPE APPLICATION, AND THE PATIENT HAS A HISTORY OF ALLERGIES. A DEVICE EVALUATION AND A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: WARNINGS: NEVER LEAVE A V.A.C.® DRESSING IN PLACE WITHOUT ACTIVE V.A.C.® THERAPY FOR MORE THAN TWO HOURS. IF THERAPY IS OFF FOR MORE THAN TWO HOURS, REMOVE THE OLD DRESSING AND IRRIGATE THE WOUND. EITHER APPLY A NEW V.A.C.® DRESSING FROM AN UNOPENED STERILE PACKAGE AND RESTART V.A.C.® THERAPY; OR APPLY AN ALTERNATE DRESSING, SUCH AS A WET TO MOIST GAUZE, AS APPROVED DURING TIMES OF EXTREME NEED, BY TREATING PHYSICIAN. 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. ACRYLIC ADHESIVE AND SILICONE LAYER: THE V.A.C.® DRAPE HAS AN ACRYLIC ADHESIVE COATING, WHICH MAY PRESENT A RISK OF AN ADVERSE REACTION IN PATIENTS WHO ARE ALLERGIC OR HYPERSENSITIVE TO ACRYLIC ADHESIVES. THE DERMATAC DRAPE HAS AN ACRYLIC ADHESIVE COATING AND A SILICONE LAYER, WHICH MAY PRESENT A RISK OF AN ADVERSE REACTION IN PATIENTS WHO ARE ALLERGIC OR HYPERSENSITIVE TO ACRYLIC ADHESIVES OR SILICONE. IF A PATIENT HAS A KNOWN ALLERGY OR HYPERSENSITIVITY TO SUCH MATERIALS, DO NOT USE THE V.A.C.® THERAPY SYSTEM. IF ANY SIGNS OF ALLERGIC REACTION OR HYPERSENSITIVITY DEVELOP, SUCH AS REDNESS, SWELLING, RASH, URTICARIA OR SIGNIFICANT PRURITUS, DISCONTINUE USE AND CONSULT A PHYSICIAN IMMEDIATELY. IF BRONCHOSPASM OR MORE SERIOUS SIGNS OF ALLERGIC REACTION APPEAR, SEEK IMMEDIATE MEDICAL ASSISTANCE. PRECAUTIONS PROTECT PERIWOUND SKIN: CONSIDER USE OF A SKIN PREPARATION PRODUCT TO PROTECT PERIWOUND SKIN WHEN USING V.A.C.® DRAPE. DO NOT ALLOW FOAM TO OVERLAP ONTO INTACT SKIN. PROTECT FRAGILE/ FRIABLE PERIWOUND SKIN WITH ADDITIONAL DRAPE, HYDROCOLLOID OR OTHER TRANSPARENT FILM. - MULTIPLE LAYERS OF DRAPE MAY DECREASE THE MOISTURE VAPOR TRANSMISSION RATE, WHICH MAY INCREASE THE RISK OF MACERATION. - IF ANY SIGNS OF IRRITATION OR SENSITIVITY TO THE DRAPE, FOAM OR TUBING ASSEMBLY APPEAR, DISCONTINUE USE AND CONSULT A PHYSICIAN. - TO AVOID TRAUMA TO THE PERIWOUND SKIN, DO NOT PULL OR STRETCH THE DRAPE OVER THE FOAM DRESSING DURING DRAPE APPLICATION. - EXTRA CAUTION SHOULD BE USED FOR PATIENTS WITH NEUROPATHIC ETIOLOGIES OR CIRCULATORY COMPROMISE. DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A KINETIC CONCEPTS, INC. PRODUCT MALFUNCTIONED, IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE WOUND CARE NURSE: THE PATIENT HAD A SEVERE RASH ALLEGEDLY FROM PRODUCT IN V.A.C.® DRESSING AND DRAPE SPRAY. ON 03-APR-2024, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE WOUND CARE NURSE: ON (B)(6) 2024, V.A.C.® THERAPY WAS INITIALLY APPLIED WITH PLACEMENT OF V.A.C. WHITEFOAM¿ DRESSING IN TUNNELED AREA AND V.A.C.® GRANUFOAM¿ DRESSING IN BED OF WOUND. SUREPREP SPRAY (NON-KCI PRODUCT) WAS APPLIED TO PERIWOUND, PRIOR TO V.A.C.® DRAPE APPLICATION. PATIENT RETURNED TO WOUND CARE CENTER ON (B)(6) 2024 FOR DRESSING CHANGE. THE PERIWOUND EXHIBITED A "PIMPLE-LIKE" RASH. THE PATIENT HAD HIVES TO ARMS AND LEGS AND THE RIGHT LEG WAS SWOLLEN AND FLUSHED RED, BEYOND THE V.A.C.® DRAPE AREA. PATIENT WAS TREATED WITH ORAL BENADRYL AND AN INTRAMUSCULAR (IM) INJECTION OF DECADRON. V.A.C.® THERAPY WAS REAPPLIED. ON (B)(6) 2024, PATIENT CAME IN TO WOUND CARE CENTER WITHOUT V.A.C.® THERAPY ON. PATIENT REPORTED THAT HE WENT TO THE EMERGENCY ROOM (ER) ON (B)(6) 2024 DUE TO WORSENING SYMPTOMS. PATIENT REPORTED HIS FACE AND EYES HAD STARTED SWELLING. ER STAFF ADMINISTERED ANOTHER IM INJECTION OF DECADRON AND REMOVED V.A.C.® THERAPY. NURSE PRACTITIONER BELIEVES THE ALLERGIC REACTION WAS CAUSED BY THE POLYURETHANE IN THE V.A.C.® GRANUFOAM¿ DRESSING, POSSIBLY THE V.A.C. WHITEFOAM¿ DRESSING, AND THE SUREPREP SPRAY. PATIENT IS HIGHLY ALLERGIC TO SHELLFISH AND HORSES AND DENIED ANY CONTACT. PATIENT WAS SEEN AGAIN ON (B)(6) 2024 AND HAD FULLY RECOVERED. THE V.A.C. WHITEFOAM¿ DRESSING LOT NUMBER WAS NOT PROVIDED, AND THE PRODUCT WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION AND A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE ALLEGED ALLERGIC REACTION TO V.A.C.® GRANUFOAM¿ DRESSING IS REPORTED UNDER MDR-3009897021-2024-00023. THE ALLEGED ALLERGIC REACTION TO V.A.C. WHITEFOAM¿ DRESSING IS REPORTED UNDER MDR-3009897021-2024-00025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070594 V.A.C. WHITEFOAM¿ DRESSING OMP OMP KINETIC CONCEPTS, INC. VACDSP ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male Required Intervention