BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNBRANDED

    MDR report key: 24115179 · Received January 20, 2026

    Report

    Report Number
    24115179
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    December 8, 2025
    Report Date
    December 29, 2025
    Manufacturer
    ADVANCE MEDICAL DESIGNS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE SETTING UP FOR SURGICAL PROCEDURE, UPON OPENING THE SNAP KOVER REF 01-3630 - STERILE DRAPE TO PLACE ON STERILE FIELD, AN UNKNOWN DARK COLORED OBJECT WAS NOTED AGAINST THE TRANSPARENT DRAPE. THE ITEM WAS ISOLATED AND REMOVED FROM THE SURGICAL SUITE, AFTER A CLOSER LOOK IT APPEARS TO HAVE THE SILHOUETTE OF AN INSECT INSIDE THE STERILE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178812 UNBRANDED SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA ADVANCE MEDICAL DESIGNS, INC. 01-3630 50716C4084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown