BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL ACTION INDUSTRIES INC. SPONGE: LAP 18X18 W XR

    MDR report key: 11574094 · Received March 26, 2021

    Report

    Report Number
    11574094
    Event Type
    Malfunction
    Date Received
    March 26, 2021
    Date of Event
    March 19, 2021
    Report Date
    March 23, 2021
    Manufacturer
    MEDICAL ACTION INDUSTRIES INC.
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EXCESSIVE LINT COMING FROM THE LAP SPONGES AND THE HOSPITAL LAUNDERED STERILE BLUE TOWELS, CREATING POSSIBLE CONTAMINATION. ONE SURGEON HAS COMPLAINED OF THIS OCCURRING. NO OTHER ISSUES VOICED FROM THIS SURGEON SINCE THE INITIAL COMPLAINT. NO OTHER SURGEONS HAVE VOICED CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475023 MEDICAL ACTION INDUSTRIES INC. SPONGE: LAP 18X18 W XR GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY MEDICAL ACTION INDUSTRIES INC. 402 1904JK304A

    Patients

    Seq Age Sex Outcome Treatment
    1 26280 DA