BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AART GLUTEAL IMPLANTS

    MDR report key: 23716391 · Received December 4, 2025

    Report

    Report Number
    3003897287-2025-00001
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    July 27, 2025
    Report Date
    December 3, 2025
    Manufacturer
    DSAART, LLC
    Product Code
    MIB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PATIENT EXPRIENCED SLOW HEALING WOUNDS AT INCISION SITE AND A SEROMA. TWO MONTHS AFTER SURGERY, INCISION SITE WAS 80% HEALED AND THE PHYSICAN DRAINED EXCESS FLUID. THREE MONTHS AFTER SURGERY, PATIENT RETURNED TO THE PHYSICAN WHERE NECROTIC TISSUE WAS FOUND. NECROTIC TISSUE WAS DEEMED TO BE NON-INFECTOUS AND WAS REMOVED AROUND IMPLANT. PATIENT HAS NOT SEEN PHYSICAN SINCE THEN.THE SEROMA AT INCISION SITE IS BELIEVED TO HAVE DELAYED HEALING AND CAUSED PRESSURE ON THE BLOOD VESSELS LEADING TO POOR CIRCULATION AND DEAD TISSUE (NECROSIS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2800803 AART GLUTEAL IMPLANTS GLUTEAL IMPLANTS MIB DSAART, LLC E 24-06-017

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention