BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADAPTIC NON-ADHERING DRESSING

    MDR report key: 2743368 · Received September 9, 2012

    Report

    Report Number
    3007663067-2012-00004
    Event Type
    Other
    Date Received
    September 9, 2012
    Date of Event
    August 20, 2012
    Report Date
    September 7, 2012
    Manufacturer
    SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED
    Product Code
    FRO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA 09/07/2012. CONCLUSION CODE: REMOVAL DIFFICULTIES. THE PROCEDURE WAS CARRIED OUT ON THE SAME PT SEVERAL TIMES WITH NO ISSUES. THE VACVIA WAS LEFT ON CONTINUOUSLY BETWEEN FRIDAY (B)(6) (WHEN THE BLACK SPONGE WAS REMOVED). PT HAD NO ILL EFFECTS IMMEDIATELY AFTER THE EVENT. PT IS AWAITING SURGERY WITH PLASTIC SURGEON TO REMOVE THE KNITTED CELLULOSE ACETATE NON-ADHERENT DRESSING. THE BLACK GRANUFOAM SUPPLIED WITH THE VACVIA KIT IS A HYDROPHOBIC DRESSING AND IS DESIGNED TO STIMULATE EXUBERANT GRANULATION TISSUE. WHEN USED WITH VAC THERAPY IT IS ALWAYS POSSIBLE TO HAVE AN INGROWTH OF GRANULATION TISSUE INTO THE FOAM AND/OR INTERFACE DRESSING.

    Description of Event or Problem · 1

    KNITTED CELLULOSE ACETATE NON-ADHERENT DRESSING APPLIED TO BASE OF WOUND. BLACK FOAM PLACED OVER IT, SEALED AND KCI VACVIA MACHINE APPLIED. THE ABOVE PROCEDURE HAD BEEN CARRIED OUT SEVERAL TIMES OVER THE LAST FEW WEEKS AT THIS PRACTICE IN THE WOUND HEALING DEPT WITH NO ISSUES. ON (B)(6) 2012 THE VACVIA WAS DISCONNECTED, THE BLACK FOAM REMOVED. KNITTED CELLULOSE ACETATE NON-ADHERENT DRESSING WAS ALMOST INVISIBLE. GRANULATION TISSUE HAD GROWN UP THROUGH IT, SO NURSE IS UNABLE TO REMOVE THE DRESSING.

    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 UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other