BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE ACCU-SORB X-RAY DETECTABLE GAUZE SPONGES

    MDR report key: 23296160 · Received October 15, 2025

    Report

    Report Number
    MW5177350
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    October 6, 2025
    Report Date
    October 6, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    NAB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING PROCEDURE IT WAS NOTED THAT THE MEDLINE ACCU-SORB X-RAY DETECTABLE GAUZE SPONGE'S FIBERS WERE NOT SECURELY WOVEN. SPONGE REMOVED DUE TO CONCERNS FOR RETAINED FOREIGN BODY. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2374791 MEDLINE ACCU-SORB X-RAY DETECTABLE GAUZE SPONGES GAUZE / SPONGE,NONRESORBABLE FOR EXTERNAL USE NAB MEDLINE INDUSTRIES, LP - NORTHFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female