BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTIC NON-ADHERING DRESSING

    MDR report key: 2556363 · Received April 26, 2012

    Report

    Report Number
    3007663067-2012-00001
    Event Type
    Injury
    Date Received
    April 26, 2012
    Date of Event
    March 23, 2012
    Report Date
    April 26, 2012
    Manufacturer
    SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED
    Product Code
    FRO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA (B)(4) 2012. (B)(4) - DEVICE INCORRECT CARE/USE OF. THE PT'S DRESSING WAS DUE TO BE REMOVED AS IT WAS DAY 5 POST OP SKIN GRAFT. THE MEDICAL OFFICER REMOVED THE DRESSING AND NOTED THAT THE NEW GRAFT HAD A CHECKERED APPEARANCE AND A PIECE OF DRESSING SEEN UNDER GRAFT. THE MEDICAL OFFICER PULLED ON THE TAIL OF AN EXPOSED PIECE OF FABRIC AT THE BASE OF THE WOUND. ADAPTIC INSTRUCTIONS FOR USE STATES 'CUT ADAPTIC TO SIZE IF REQUIRED AND PLACE DIRECTLY ON THE WOUND', WHICH HAD BEEN UNDER THE NEW GRAFT. THREE STAFF MEMBERS INSPECTED THE WOUND BED PRIOR TO GRAFTING, NO ONE NOTICED THAT ADAPTIC IN THE WOUND.

    Description of Event or Problem · 1

    KNITTED CELLULOSE ACETATE NON-ADHERENT DRESSING WAS USED PRE SKIN GRAFT. REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. HOSPITAL HAS STATED; TEMPORARY HARM - HARM SUSTAINED TO SOFT TISSUE WITH SOME MINOR LOCALIZED DAMAGE TO THE CIRCULATORY/VASCULATURE. SOME PSYCHOLOGICAL IMPACT DUE TO DELAYED HEALING AND FURTHER SURGICAL INTERVENTIONS. FURTHER SURGERY MAY BE REQUIRED TO REGRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTIC NON-ADHERING DRESSING SURGICAL WOUND, NON-ADHERING DRESSING FRO SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED 2012 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention