BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHO-GLASS SPLINTING SYSTEM

    MDR report key: 5768608 · Received July 5, 2016

    Report

    Report Number
    5768608
    Event Type
    Injury
    Date Received
    July 5, 2016
    Date of Event
    May 19, 2016
    Report Date
    June 30, 2016
    Manufacturer
    BSN MEDICAL
    Product Code
    ITG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT STATUS POST RIGHT FEMUR INTRAMEDULLARY FIXATION. THE PATIENT DEVELOPED AN UNSTAGEABLE PRESSURE ULCER. THE LESION IS LOCATED ON THE RIGHT HEEL AND MEASURES 3.5CMX4 CM. TREATMENT HAS BEEN INITIATED AND WILL BE MONITORED BY THE WOUND CARE TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422258 ORTHO-GLASS SPLINTING SYSTEM BANDAGE, CAST ITG BSN MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other| R OTHER, BUCKS TRACTION