BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 2051089 · Received April 5, 2011

    Report

    Report Number
    1625774-2011-00046
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INTENDED FOR SINGLE USE ONLY AND WAS DISPOSED OF. THEREFORE, THE DEVICE WAS NOT AVAILABLE FOR EVAL. DEVICE LABELING IN PRINT AND ON-LINE STATES: "WOUNDS BEING TREATED WITH THE V.A.C. THERAPY SYS SHOULD BE MONITORED ON A REGULAR BASIS. IN A MONITORED, NON-INFECTED WOUND, V.A.C. DRESSINGS SHOULD BE CHANGED EVERY 48 TO 72 HOURS; BUT NO LESS THAN 3 TIMES PER WEEK, WITH FREQUENCY ADJUSTED BY THE CLINICIAN AS APPROPRIATE."

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO KCI BY THE HEALTHCARE PROVIDER: THE PT WAS ON V.A.C. VIA THERAPY FROM (B)(6) 2011, UNTIL (B)(6) 2011. ON (B)(6) 2011, THE HOME HEALTH AGENCY ADMITTED THE PT AND WAS GIVEN PHYSICIAN ORDERS TO NOT REMOVE THE PT'S V.A.C. VIA DRESSING. ON (B)(6) 2011, THE PT CONTACTED THE HOME HEALTH AGENCY TO REPORT THE DEVICE WAS OFF AND REQUESTED INSTRUCTION ON WHAT TO DO. WHEN THE NURSE TOLD THE PT THE DRESSING WOULD NEED TO BE REPLACED, THE PT REFUSED. THE HOME HEALTH AGENCY CONTACTED THE PHYSICIAN WHO ORDERED THE PT TO BE RE-ADMITTED TO THE HOSPITAL FOR DRESSING REMOVAL. THE PT WAS ADMITTED TO THE HOSPITAL FOR AN OUTPATIENT PROCEDURE TO REMOVE THE V.A.C. VIA DRESSING UNDER GENERAL ANESTHESIA. ON (B)(6) 2011, THE PT WAS DISMISSED FROM THE HOSPITAL IN GOOD CONDITION ON AN ALTERNATIVE DRESSING. THE PT WAS REPORTED TO HAVE BEEN WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V.A.C. THERAPY SYSTEM OMP KCI USA, INC. V.A.C. VIA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R