BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASIC ORTHO TRAY LARGE SPONGES / BASIC ORTHO TRAY

    MDR report key: 11648200 · Received April 9, 2021

    Report

    Report Number
    MW5100701
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    April 7, 2021
    Report Date
    April 8, 2021
    Manufacturer
    MEDLINE INDUSTRIES, INC. - LAREDO
    Product Code
    OJH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE BLUE RADIOPAQUE STRIPS SEPARATED AT THE SPONGE OF 2 OF 5 LARGE SPONGES IN THE BASIC ORTHO TRAY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542249 BASIC ORTHO TRAY LARGE SPONGES / BASIC ORTHO TRAY ORTHOPEDIC TRAY OJH MEDLINE INDUSTRIES, INC. - LAREDO DYNJ49369 20JBC475

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR