BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C THERAPY

    MDR report key: 3121925 · Received May 15, 2013

    Report

    Report Number
    3009897021-2013-00042
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 15, 2013
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE PT'S MEDICAL RECORD, THE PT FAILED TO FOLLOW UP FOR WOUND CARE. THE PT'S MEDICAL RECORDS INDICATE, "THE PT STATES THAT HE LEFT THE WOUND VAC (DRESSING) IN, DESPITE THE FACT THAT HE KNEW THAT THE SPONGE COULD BE STUCK AND REQUIRED DIFFICULT REMOVAL." ON (B)(6) 2013, THE PHYSICIAN DISCHARGED THE PT FROM THEIR SVC DUE TO NON-COMPLIANCE. VAC THERAPY WAS INITIATED ON (B)(6) 2013. BASED ON INFO PROVIDED, IT CANNOT BE DETERMINED WHEN THE FOREIGN BODY ALLEGED TO BE VAC GRANUFOAM WAS INADVERTENTLY LEFT IN THE WOUND. THE FOREIGN MATERIAL WAS NOT RETURNED TO KCI FOR IDENTIFICATION; THEREFORE, KCI IS UNABLE TO CONFIRM ITS IDENTITY. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO GATHER ADD'L INFO, BUT THERE HAS BEEN NO RESPONSE. THIS REPORT IS BEING FILED DUE TO POSSIBLE USER ERROR. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: VAC FOAM DRESSINGS ARE NOT BIOABSORBABLE. ALWAYS COUNT THE TOTAL NUMBER OF PIECES OF FOAM REMOVED FROM THE WOUND AND ENSURE THE SAME NUMBER OF PIECES OF FOAM WAS REMOVED AS PLACED. FOAM LEFT IN THE WOUND FOR GREATER THAN THE RECOMMENDED TIME PERIOD MAY FOSTER IN-GROWTH OF TISSUE INTO THE FOAM AND CREAT DIFFICULTY IN REMOVING FOAM FRO THE WOUND OR LEAD TO INFECTION OR OTHER ADVERSE EVENTS. DRESSING CHANGES: WOUNDS BEING TREATED WITH THE VAC THERAPY SYS SHOULD BE MONITORED ON A REGULAR BASIS. IN A MONITORED, NON-INFECTED WOUND, VAC 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 PT'S CLINICAL PRESENTATION, RATHER THAN A FIXED SCHEDULE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE FOLLOWING INFO WAS REPORTED TO KCI BY THE PT'S SPOUSE: A FOREIGN BODY ALLEGED TO BE VAC GRANUFOAM HAD BEEN IN THE PT'S WOUND FOR A MONTH. THE SPOUSE ALLEGED OBSERVING A "BAD SMELL," AND "PUS COMING FROM THE WOUND." PER THE PT'S MEDICAL RECORDS, ON AN UNK DATE, THE PT PRESENTED TO THE EMERGENCY ROOM WITH THE COMPLAINT OF AN INABILITY TO REMOVE THE FOREIGN BODY. THE EMERGENCY ROOM PHYSICIAN WAS UNABLE TO REMOVE THE FOREIGN BODY, AND NO SURGICAL INTERVENTION WAS PERFORMED. ON (B)(6) 2013, THE PT'S PHYSICIAN OBSERVED A FOREIGN BODY IN THE PT'S WOUND WITH NO EVIDENCE OF AN INFECTION. THE PHYSICIAN ATTEMPTED TO REMOVE THE FOREIGN BODY, BUT THE PT REFUSED. THE PHYSICIAN PLANNED TO SCHEDULE THE SURGICAL REMOVAL OF THE FOREIGN BODY UNDER GENERAL ANESTHESIA. ON (B)(6) 2013, THE FOLLOWING INFO WAS REPORTED TO KCI BY THE PT'S WIFE: NO SURGERY DATE HAS BEEN SCHEDULED. NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215296 V.A.C THERAPY OMP KCI USA INC. V.A.C GRANUFOAM

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R