BEUDAMED
    FDA Adverse Event Death Summary report: N

    V.A.C WHITEFOAM DRESSING

    MDR report key: 3732770 · Received March 28, 2014

    Report

    Report Number
    3009897021-2014-00016
    Event Type
    Death
    Date Received
    March 28, 2014
    Report Date
    February 27, 2014
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED DEATH IS RELATED TO V.A.C. THERAPY. IT CANNOT BE DETERMINED WHEN THE FOREIGN BODY ALLEGED TO BE V.A.C WHITEFOAM MATERIAL WAS NOT RETURNED TO KCI FOR IDENTIFICATION; THEREFORE, KCI IS UNABLE TO CONFIRM ITS IDENTITY. THIS REPOT IS BEING FILED DUE TO POSSIBLE USER ERROR.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED TO KCI BY THE PHYSICIAN : A PT WITH AN ORTHOPEDIC TYPE WOUND WAS RE-ADMITTED TO THE HOSPITAL DUE TO A RETAINED FOREIGN MATERIAL ALLEGED TO BE V.A.C. WHITEFOAM DRESSING. DATES NOT PROVED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185113 V.A.C WHITEFOAM DRESSING OMP KCI USA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death