BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. DRESSINGS

    MDR report key: 3950596 · Received July 11, 2014

    Report

    Report Number
    3009897021-2014-00100
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 13, 2014
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED WHEN THE FOREIGN BODY ALLEGED TO BE V.A.C. DRESSINGS 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 FILLED DUE TO POSSIBLE USER ERROR.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT'S MOTHER: A FOREIGN MATERIAL ALLEGED TO BE V.A.C. DRESSING WAS LEFT IN THE PATIENT'S WOUND AND WAS STUCK TO THE WOUND WHICH REQUIRED HOSPITALIZATION FOR REMOVAL. ON (B)(6) 2014 THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: ON (B)(6) 2014, THE DRESSING WAS ALLEGEDLY OBSERVED TO BE ADHERED TO THE WOUND BED. ON (B)(6) 2014, THE PHYSICIAN PERFORMED SHARP DEBRIDEMENT, IN OFFICE, TO REMOVE THE FOREIGN MATERIAL. THE NURSE CONFIRMED THAT THE PATIENT WAS NOT HOSPITALIZED. THE PATIENT WAS SUBSEQUENTLY PLACED ON WET TO DRY DRESSINGS AND IS REPORTED AS DOING "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406897 V.A.C. DRESSINGS OMP KCI USA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention