BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASIC ORTHO TRAY

    MDR report key: 11885292 · Received May 25, 2021

    Report

    Report Number
    MW5101546
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    May 23, 2021
    Report Date
    May 24, 2021
    Manufacturer
    MEDLINE INDUSTRIES, INC. -SPT
    Product Code
    OJH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A DARK HAIR WAS FOUND WITHIN A STERILE MEDLINE BASIC ORTHO TRAY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772846 BASIC ORTHO TRAY ORTHOPEDIC TRAY OJH MEDLINE INDUSTRIES, INC. -SPT DYNJ49369 21CBE245

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR