BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 11871186 · Received May 24, 2021

    Report

    Report Number
    1416980-2021-03113
    Event Type
    Injury
    Date Received
    May 24, 2021
    Report Date
    May 24, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MKY
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: THE REPORTED PRODUCT IS AN UNKNOWN BAXTER DERMA CLOSE PRODUCT. LITERATURE ARTICLE: MACKAY, B., J., DARDANO, A., N., KLAPPER, A., M., PAREKH, S., G., SOLIMAN, M., Q., AND VALERIO I., L. ¿MULTIDISCIPLINARY APPLICATION OF AN EXTERNAL TISSUE EXPANDER DEVICE TO IMPROVE PATIENT OUTCOMES: A CRITICAL REVIEW¿. ADVANCES IN WOUND CARE. 2020 SEP;9(9):525-538. DOI: 10.1089/WOUND.2019.1112. EPUB 2020 FEB 19. THE DEVICE WAS NOT RETURNED, AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A STUDY WAS PERFORMED IN WHICH SEVEN PATIENTS UNDERWENT SCALP AND FOREHEAD RECONSTRUCTION FOR MALIGNANT NEOPLASM WITH USE OF DERMACLOSE FOR CONTINUOUS EXTERNAL TISSUE EXPANSION. DERMACLOSE WAS APPLIED INTRAOPERATIVELY AND REMAINED FOR 6 TO 14 DAYS. ONE PATIENT REQUIRED BILATERAL ADVANCEMENT ROTATION FLAPS, AND ANOTHER PATIENT HEALED BY SECONDARY INTENTION AFTER DEVICE REMOVAL. THE TWO PATIENTS EXPERIENCED WOUND DEHISCENCE AFTER PRIMARY CLOSURE, 1¿2 WEEKS AFTER STAPLE REMOVAL. TREATMENT FOR THE EVENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767735 NI SYSTEM, SKIN CLOSURE MKY BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other