BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1241081 · Received November 20, 2008

    Report

    Report Number
    1625774-2008-00057
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 27, 2008
    Manufacturer
    KCI USA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K062227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE NURSE PRACTITIONER AS WELL AS THE WOUND CARE NURSE INDICATED THAT THE ALLERGY/IMMUNOLOGY STAFF WERE NOT "100% CONVINCED" THAT THE V.A.C. GRANUFOAM SILVER WAS THE PRODUCT THAT CAUSED THE REACTION. A PATCH TEST WAS NOT PERFORMED PRIOR TO PLACEMENT OF THE FOAM. THE NURSE PRACTITIONER ALSO STATED THAT THE PATIENT HAD BEEN RECEIVING V.A.C. THERAPY USING THE V.A.C. GRANUFOAM AND V.A.C. WHITEFOAM SINCE 2008, WITHOUT ISSUE PRIOR TO THIS EVENT. V.A.C. LABELING CONTRAINDICATES THE USE OF THE V.A.C. GRANUFOAM SILVER DRESSING IN PATIENT'S WITH A SENSITIVITY TO SILVER.

    Description of Event or Problem · 1

    THE NURSE PRACTITIONER REPORTED THAT A PATIENT, WITH A HISTORY OF SYSTEMIC REACTIONS TO MULTIPLE ALLERGENS, DEVELOPED A SYSTEMIC RASH AND RESPIRATORY DISTRESS APPROXIMATELY TWO HOURS AFTER BEGINNING TREATMENT WITH V.A.C. GRANUFOAM SILVER. V.A.C. THERAPY WAS DISCONTINUED FOR THE WEEKEND AND PATIENT WAS ADMINISTERED IV STEROIDS AND H+ INHIBITORS. V.A.C. THERAPY WAS REAPPLIED AFTER THE WEEKEND USING V.A.C. GRANUFOAM AND V.A.C. WHITEFOAM WITHOUT FURTHER ISSUES. ACCORDING TO THE NURSE PRACTITIONER, THE PATIENT WAS DISCHARGED HOME WITH V.A.C. THERAPY IN 2008.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention