BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL KNEE [PACK]

    MDR report key: 11812094 · Received May 11, 2021

    Report

    Report Number
    MW5101301
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 10, 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

    MEDLINE TOTAL KNEE PROCEDURE PACK WITH HOLE IN STERILE TABLE COVER. OUTSIDE CLEAR, PROTECTIVE COVER INTACT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706026 TOTAL KNEE [PACK] ORTHOPEDIC TRAY OJH MEDLINE INDUSTRIES, INC. - SPT CMPJ05911 21CBE188

    Patients

    Seq Age Sex Outcome Treatment
    1