BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1288578 · Received January 14, 2009

    Report

    Report Number
    1625774-2009-00003
    Event Type
    Injury
    Date Received
    January 14, 2009
    Date of Event
    November 1, 2008
    Report Date
    December 16, 2008
    Manufacturer
    KCI USA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    V.A.C. LABELING STATES, "WRAP ANY EXCESS TUBING INTO A BUNDLE AND PUT THE TUBING INTO THE TUBING STORAGE POCKET ON THE BOTTOM OF THE CARRYING CASE." IN ADDITION TO THE TEXT, A PICTORIAL ILLUSTRATION IS ALSO PROVIDED. V.A.C. LABELING ALSO WARNS, "EXCESS TUBING MAY PRESENT A TRIPPING HAZARD. ENSURE THAT EXCESS TUBING IS STORED IN THE TUBING POCKET AND IS OUT OF AREAS WHERE PEOPLE MAY WALK." ALTHOUGH NO DEVICE MALFUNCTION WAS REPORTED, THE ALLEGED EVENT IS BEING REPORTED AS THE PT REQUIRED SURGICAL INTERVENTION TO RESOLVE THE CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WHO WAS RECEIVING V.A.C. THERAPY FOR A PLANTAR AREA DIABETIC ULCER WAS AMBULATING WHEN THE V.A.C. TUBING BECAME CAUGHT ON A DRESSER ALLEGEDLY CAUSING THE PT TO FALL. THE PT WAS ADMITTED TO THE HOSP FOR TREATMENT OF A BROKEN HIP AND THEN ADMITTED TO A REHABILITATION UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention