BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. GRANUFOAM DRESSING

    MDR report key: 3940257 · Received June 19, 2014

    Report

    Report Number
    3009897021-2014-00067
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    PMA / PMN Number
    K062227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFO PROVIDED, IT CANNOT BE DETERMINED WHEN THE FOREIGN BODY ALLEGED TO BE V.A.C. GRANUFOAM DRESSING WAS INADVERTENTLY LEFT IN THE WOUND. THE FOREIGN MATERIAL WAS NOT RETURNED TO KCI FOR IDENTIFICATION; THEREFORE, KCI IS UNABLE TO CONFIRM ITS IDENTITY. THIS REPORT IS BEING FILED DUE TO POSSIBLE USER ERROR.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED TO THE KCI BY THE KCI REP: THE HOME HEALTH AGENCY REPORTED THAT A FOREIGN MATERIAL ALLEGED TO BE V.A.C. DRESSING WAS EMBEDDED IN THE PT'S WOUND, AND SURGICAL INTERVENTION WAS REQUIRED. ON (B)(6) 2014, THE FOLLOWING INFO WAS REPORTED TO KCI BY THE NURSE: ON (B)(6) 2014, A FOREIGN MATERIAL ALLEGED TO BE V.A.C. GRANUFOAM DRESSING WAS RETAINED IN THE PT'S WOUND. THE SAME DAY, THE PT UNDERWENT AN OUTPATIENT SHARP DEBRIDEMENT TO REMOVE THE FOREIGN MATERIAL. V.A.C. THERAPY WAS RE-APPLIED, AND THE PT DID NOT EXPERIENCE ANY SUBSEQUENT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359487 V.A.C. GRANUFOAM DRESSING OMP KCI USA INC. WNDACT

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention