BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COTTONOID

    MDR report key: 25136293 · Received May 11, 2026

    Report

    Report Number
    25136293
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 1, 2026
    Manufacturer
    AMERICAN SURGICAL COMPANY, LLC
    Product Code
    HBA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    COTTONOID COUNT WAS OFF WITH CLOSING COUNT. WENT THROUGH TRASH AND STERILE FIELD MULTIPLE TIMES. SURGEON REOPENED INCISION FOR A RELOOK. TOOK A C ARM PICTURE WITH NOTHING DETECTED. CALLED XR TECH FOR FLATPLATE IMAGE, AGAIN NOTHING WAS DETECTED. PLACED A COTTONOID ON PATIENT'S SKIN TO SEE IF XR WAS PICKING UP THE COTTONOID AT ALL AND IT WAS NOT VISIBLE IN THE IMAGE. PACKAGE STATES THESE COTTONOID STINGS ARE BARRIUM IMPREGNATED SO THEY SHOULD BE DETECTABLE IN XRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42816 COTTONOID NEUROSURGICAL PADDIE HBA AMERICAN SURGICAL COMPANY, LLC 2025/03 BE

    Patients

    Seq Age Sex Outcome Treatment
    1