BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMACLOSE

    MDR report key: 17777531 · Received September 19, 2023

    Report

    Report Number
    1416980-2023-04737
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    July 4, 2023
    Report Date
    October 10, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MKY
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO H3 AND H6. H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. THE RETURNED PHOTOGRAPHS WERE REVIEWED, AND IT WAS NOTED THAT THE DERMACLOSE DEVICE HAD BEEN PLACED APPROPRIATELY. THE PICTURES ALSO SHOWED THAT THE WOUND HAD BEGUN TO APPROXIMATE WHICH WOULD SUGGEST THE WOUND DISPLAYED SIGNS OF HEALING. WITH THE REMOVAL OF THE DERMACLOSE AT 4 DAYS, IT IS UNKNOWN WHETHER THE DERMACLOSE WOULD HAVE CONTINUED TO APPROXIMATE THE WOUND OVER THE ALLOWED 14 DAY TIME PERIOD. PER THE DERMACLOSE CE IFU (PAGE 7): ¿THE DERMACLOSE DEVICE WILL IMMEDIATELY BEGIN TO MOBILIZE THE TISSUE AND CAN BE LEFT IN PLACE UNTIL THE DESIRED TISSUE EXPANSION HAS OCCURRED. THIS CAN TAKE ANYWHERE FROM HOUR TO DAYS DEPENDING ON WOUND LOCATION, SIZE, AND TYPE OF TISSUE. EVALUATION TISSUE MOVEMENT AFTER 48-72HRS. THE MAXIMUM LENGTH OF TIME DERMACLOSE DEVICE CAN BE LEFT ON IS FOURTEEN (14) DAYS¿. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER POSTAL CODE - (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A LACK OF WOUND CLOSURE AFTER APPLYING A DERMACLOSE KIT TO THE SKIN. A DERMACLOSE KIT WAS APPLIED TO THE SKIN WITH NO ISSUES; HOWEVER, AFTER APPROXIMATELY FOUR DAYS POST-OPERATIVELY, THE SURGEON TURNED THE PRODUCT LOOSE, AND IT WAS OBSERVED THAT THE WOUND HAD NOT APPROXIMATED. THE CAUSE OF THE LACK OF WOUND CLOSURE WAS UNKNOWN. TO RESOLVE THIS ISSUE, THE PATIENT WAS RE-OPERATED, AND A SKIN GRAFT WAS APPLIED, WITH A GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985844 DERMACLOSE SYSTEM, SKIN CLOSURE MKY BAXTER HEALTHCARE CORPORATION NA 0799117020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention JELONET DRESSING