BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AART GLUTEAL IMPLANTS

    MDR report key: 23716383 · Received December 4, 2025

    Report

    Report Number
    3003897287-2025-00002
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    July 10, 2025
    Report Date
    December 3, 2025
    Manufacturer
    DSAART, LLC
    Product Code
    MIB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DURING POST OPERATIVE FOLLOW-UP, PHYSICAN NOTICED PATIENT'S INCISION SITE HEALING WAS DELAYED, A SEROMA, AND MILD INFECTION. THE PHYSICAN DRAINED THE SEROMA AND PERSCRIBED ANTIBIOTICS TO THE PATIENT.THE PATIENT RECOVERED WITHOUT FURTHER COMPLICATIONS.SEROMA AND INFECTION CONFIRMED TO CAUSE DELAY IN HEALING. THE INFECTION WAS DETERMINED NOT TO BE ATTRIBUTABLE TO THE IMPLANT MATERIAL OR ITS SIZE/PLACEMENT. POST-OPERATIVE SURGICAL SITE INFECTION IS A WIDELY RECOGNIZED COMPLICATION AND INNATE RISK ASSOCIATED WITH ALL SURGICAL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2800796 AART GLUTEAL IMPLANTS GUTEAL IMPLANT MIB DSAART, LLC E 24-10-005

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female