BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE ORTHOPEDIC CUSTOM PACK

    MDR report key: 4931265 · Received July 2, 2015

    Report

    Report Number
    4931265
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    June 25, 2015
    Report Date
    July 1, 2015
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OJH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    ESU TIP INSULATION SPLIT/FRAYED DURING USE; LABELED MEGADYNE. WAS CONTAINED IN A MEDLINE CUSTOM PACKAGE; "CMC POSTERIOR SPINE-LF" REF# DYNJ22119F, LOT #15MB673.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433303 MEDLINE ORTHOPEDIC CUSTOM PACK ORTHOPEDIC TRAY OJH MEDLINE INDUSTRIES, INC. * 15MB673

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR