BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMACLOSE

    MDR report key: 22093397 · Received May 27, 2025

    Report

    Report Number
    1416980-2025-03062
    Event Type
    Injury
    Date Received
    May 27, 2025
    Report Date
    May 27, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MKY
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    DURING A SURVEY, AN UNSPECIFIED HEALTHCARE WORKER RESPONDED ¿6-15% OF PATIENTS EXPERIENCE WOUND DEHISCENCE AFTER PRIMARY SURGICAL CLOSURE¿ WHEREIN DERMACLOSE WAS REMOVED. ADDITIONALLY, THE RESPONDENT STATED, ¿THESE ARE TYPICALLY HIGH RISK TO BEGIN WITH; SO UNCLEAR WHETHER THE WOUND HEALING FAILURE WAS DUE TO DERMACLOSE OR THE SUBSTRATE¿. THIS EVENT LIKELY REQUIRED MEDICAL INTERVENTION IN ORDER TO PRECLUDE PERMANENT IMPAIRMENT. THE RESPONDENT ANSWERED ANONYMOUSLY; THEREFORE, FOLLOW UP INFORMATION WAS NOT ABLE TO BE OBTAINED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014342 DERMACLOSE SYSTEM, SKIN CLOSURE MKY BAXTER HEALTHCARE CORPORATION NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention