BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASIC ORTHO TRAY

    MDR report key: 11938456 · Received June 3, 2021

    Report

    Report Number
    MW5101705
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 30, 2021
    Report Date
    June 2, 2021
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OJH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ONLY 4 OF 5 "LAP SPONGE 12X12 X-RAY" PRESENT IN MEDLINE BASIC ORTHO TRAY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832066 BASIC ORTHO TRAY ORTHOPEDIC TRAY OJH MEDLINE INDUSTRIES, INC. DYNJ49369 20JBC475

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR