BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLCARE

    MDR report key: 24477493 · Received March 2, 2026

    Report

    Report Number
    24477493
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    July 14, 2025
    Report Date
    February 5, 2026
    Manufacturer
    ALLCARE, INC
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    LAP SPONGES WERE ADDED TO CASE TOWARD END OF PROCEDURE AND COUNTED. RELIEF SCRUB FOUND SMALL BLACK HAIR WHILE RE-ORGANIZING. LAPS WERE SEQUESTERED, MAYO REMOVED, AND GLOVES CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540172 ALLCARE GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY ALLCARE, INC AL1818 2IXL06

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other