BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1980325 · Received February 3, 2011

    Report

    Report Number
    1625774-2011-00007
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    December 31, 2010
    Report Date
    January 6, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES THE VAC DRAPE HAS AN ACRYLIC ADHESIVE COATING, WHICH MAY PRESENT A RISK OF AN ADVERSE REACTION IN PATIENTS WHO ARE ALLERGIC ON HYPERSENSITIVE TO ACRYLIC ADHESIVES. IF A PATIENT HAS A KNOWN ALLERGY OR HYPERSENSITIVITY TO SUCH ADHESIVES, DO NOT USE THE VAC THERAPY SYSTEM. IF ANY SIGNS OF ALLERGIC REACTION OR HYPERSENSITIVITY DEVELOP, SUCH AS REDNESS, SWELLING, RASH, URTICARIA, OR SIGNIFICANT PRURITUS, DISCONTINUE USE AND CONSULT PHYSICIAN IMMEDIATELY.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO KCI: IT WAS REPORTED THAT VAC THERAPY WAS DISCONTINUED ON (B)(6) 2010, DUE TO AN ALLEGED REACTION TO THE DRAPE RESULTING IN BLISTERS THAT WERE NOT HEALING. ON (B)(6) 2011, IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED AN ALLERGY TO THE V.A.C. DRAPE. ON AN UNKNOWN DATE, ONE OF THE BLISTERS BECAME INFECTED AND REQUIRED A SHARP DEBRIDEMENT. THE PATIENT PLACED ON CIPRO BY MOUTH TWICE A WEEK. IT WAS REPORTED THAT ON (B)(6) 2011, THE BLISTERS WERE RESOLVING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention