BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL HIP PACK

    MDR report key: 11790067 · Received May 6, 2021

    Report

    Report Number
    MW5101230
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 5, 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

    TWO (2) MEDLINE TOTAL HIP PROCEDURE AND TOTAL HIP PACKS WITH COMPROMISED (HOLES) IN THE TABLE COVER UPON OPENING OF THE STERILE PACK. THE CLEAR, OUTSIDE DUST COVER WAS INTACT FOR BOTH PACKS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683568 TOTAL HIP PACK ORTHOPEDIC TRAY OJH MEDLINE INDUSTRIES, INC. DYNJ901823 21ABL238
    683569 O.R. TOTAL HIP PACK ORTHOPEDIC TRAY OJH MEDLINE INDUSTRIES, INC. CMPJ05910 21ABT006

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR