BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 11871424 · Received May 24, 2021

    Report

    Report Number
    1416980-2021-03114
    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

    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 A PATIENT UNDERWENT A MEDIAN STERNOTOMY FOR AORTIC VALVE REPLACEMENT AND SUBSEQUENTLY DEVELOPED A POSTOPERATIVE INFECTION. AFTER FOUR DAYS OF WOUND VACUUM-ASSISTED CLOSURE, SKIN AND SUBCUTANEOUS FAT WERE UNDERMINED AND DERMACLOSE (CONTINUOUS EXTERNAL TISSUE EXPANSION) WAS APPLIED FOR SEVEN DAYS. A SOFT FOAM DRESSING WAS PLACED UNDERNEATH THE DEVICE TO PROTECT UNDERLYING SKIN; HOWEVER, THE PATIENT EXPERIENCED SOME BLISTERING ON THE BREASTS. THE PATIENT WAS TREATED WITH ¿LOCAL WOUND CARE¿ (NO FURTHER DETAILS). THE PATIENT OUTCOME WAS REPORTED AS ¿THIS HEALED FULLY WITH LOCAL WOUND CARE¿ AND WAS "COMPLETELY HEALED BY THE 5 MONTH FOLLOW UP". NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769679 NI SYSTEM, SKIN CLOSURE MKY BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention