BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORM FIT NIGHT SPLINT

    MDR report key: 6112841 · Received November 18, 2016

    Report

    Report Number
    2085446-2016-00007
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    October 22, 2016
    Report Date
    December 8, 2016
    Manufacturer
    OSSUR AMERICAS
    Product Code
    ITW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED A FORM FIT NIGHT SPLINT BRACE FOR USE POST-OPERATIVE FROM HIP LABRAL REPAIR. PATIENT HAD A STAGE 1 PRESSURE ULCER ON HER HEEL AFTER THE 2ND DAY WEARING THE SPLINT.

    Description of Event or Problem · 1

    PATIENT RECEIVED A FORM FIT NIGHT SPLINT BRACE FOR USE POST-OPERATIVE FROM HIP LABRAL REPAIR. PATIENT HAD A STAGE 1 PRESSURE ULCER ON HER HEEL AFTER THE 2ND DAY WEARING THE SPLINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765761 FORM FIT NIGHT SPLINT JOINT, ANKLE, EXTERNAL BRACE ITW OSSUR AMERICAS 50033

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other| R