BEUDAMED
    FDA Adverse Event Other Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 745726 · Received August 4, 2006

    Report

    Report Number
    1625774-2006-00038
    Event Type
    Other
    Date Received
    August 4, 2006
    Report Date
    July 7, 2006
    Manufacturer
    KCI USA, INC.
    Product Code
    JCX
    PMA / PMN Number
    k032310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO PROVIDED BY THE HEALTH CARE PROVIDER INDICATES THAT THE WOUND CARE NURSE REALIZED THAT THE WOUND HAD GRANULATED INTO THE FOAM WHEN SHE HAD DIFFICULTY REMOVING THE DRESSING. THE DRESSING WAS APPLIED WITHOUT A NON-ADHERENT LAYER AND WAS LEFT ON THE WOUND FOR 72 HOURS. THE HEALTH CARE PROVIDER FURTHER INDICATED THAT THE GRANUFOAM WAS VISIBLE IN THE WOUND BED AND THE SURGEON WAS GOING TO TRY TO DO A SHARP DEBRIDEMENT AT THE BEDSIDE, BUT DECIDED TO DO IT IN THE OPERATING ROOM BECAUSE THE PT WAS ON LOVENOX AND WAS PRONE TO BLEEDING AND ON A VENTILATOR. V.A.C. THERAPY LABELING STATES: "ROUTINE DRESSING CHANGES SHOULD OCCUR EVERY 48 HOURS".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT HAD RETAINED GRANUFOAM IN AN ABDOMINAL WOUND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention