BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C.ULTA¿ THERAPY

    MDR report key: 6113115 · Received November 18, 2016

    Report

    Report Number
    3009897021-2016-00097
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    October 20, 2016
    Report Date
    November 18, 2016
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K100657
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STAGE II PRESSURE SORE, WHICH ALLEGEDLY DEVELOPED DUE TO V.A.C. WHITEFOAM DRESSING WOULD USUALLY BE TREATED CONSERVATIVELY WITHOUT SURGICAL INTERVENTION, AND WOULD THEREFORE, NOT TO MEET THE DEFINITION OF A SERIOUS INJURY AS DEFINED IN OUR INTERNAL PROCEDURES WHICH ARE ALIGNED WITH 21 CFR 803.3. KCI IS REPORTING THIS EVENT DUE TO THE PHYSICIAN'S ALLEGATION THAT ALTHOUGH THE PATIENT HAS MULTIPLE COMORBIDITIES THAT MAY HAVE CONTRIBUTED TO THE INFECTION DEVELOPMENT, THE INFECTION MAY NOT HAVE DEVELOPED IF THE PRESSURE SORE WAS NOT PRESENT. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: 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.

    Description of Event or Problem · 1

    ON OCT 20 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PHYSICIAN: THE PHYSICIAN CALLED TO REPORT THE WOUND DESCRIPTION OF A POST GRAFT PLACEMENT. THE PHYSICIAN REPORTED THAT HE PLACED V.A.C. WHITEFOAM DRESSING OVER THE GRAFT, OVERLAP THE V.A.C. WHITEFOAM DRESSING 1CM AROUND THE GRAFT SITE, AND COVER THE GRAFT WITH TRANSPARENT TAPE. THE DRESSING WAS REMOVED 5 DAYS POST GRAFT PLACEMENT, AND THE PHYSICIAN OBSERVED GRAFT ADHERENCE EXCEPT FOR A LOCATION IN THE WOUND WITH A FOREIGN MATERIAL ALLEGED TO BE V.A.C. WHITEFOAM DRESSING EMBEDDED INTO THE SKIN WHICH ALLEGEDLY CAUSED A PRESSURE SORE THAT REQUIRES TREATMENT. ON OCT 27 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PHYSICIAN: THE PHYSICIAN CONFIRMED THE SKIN GRAFT WAS 100% TAKE. THE PHYSICIAN ALSO REPORTED THE PATIENT DEVELOPED A STAGE II PRESSURE ULCER ALLEGEDLY FROM THE V.A.C. WHITEFOAM DRESSING WHICH SUBSEQUENTLY DEVELOPED AN INFECTION, AND THE PATIENT WAS HOSPITALIZED ON (B)(6) 2016 FOR INTRAVENOUS ANTIBIOTIC TREATMENT. THE PHYSICIAN NOTED THAT THE PATIENT DOES HAVE MULTIPLE COMORBIDITIES THAT MAY HAVE CONTRIBUTED TO THE INFECTION DEVELOPMENT, BUT PER THE PHYSICIAN, THE INFECTION MAY NOT HAVE DEVELOPED IF THE PRESSURE SORE WAS NOT PRESENT. THE V.A.C. WHITEFOAM DRESSING WAS DISCARDED SO NO LOT NUMBER IS AVAILABLE. THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. ON AUG 16 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 (B)(6) 2016, THE DEVICE WAS PLACED WITH THE PATIENT. ON NOV 09 2016, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI FIELD SERVICE, THERE WAS NO FAULT FOUND WITH THE UNIT RELATED TO THE WOUND ALLEGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765910 V.A.C.ULTA¿ THERAPY OMP OMP KCI USA, INC. WNDULT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R