BEUDAMED
    FDA Adverse Event Other Summary report: N

    1937 GENTLETOUCH PILLOW

    MDR report key: 1666428 · Received April 20, 2010

    Report

    Report Number
    2921578-2010-00006
    Event Type
    Other
    Date Received
    April 20, 2010
    Date of Event
    January 12, 2010
    Report Date
    April 19, 2010
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE DISCUSSED WITH THE FACILITY ON THE USE OF THE PILLOW AND TO ENSURE THE PATIENT'S EYES ARE CENTERED IN THE PILLOW OPENING. THE FACILITY STATED THEY WERE PLACING THE OXYGEN MASK ON THE TABLE AND PLACING THE OXYGEN MASK ON THE TABLE AND PLACING THE PILLOW OVER AND THEN THE PATIENT IS PLACED ON THE PILLOW.

    Description of Event or Problem · 1

    TWO SEPARATE PATIENTS SUFFERED FROM EYE IRRITATION WHILE FACE DOWN ON A 1937 GENTLETOUCH PILLOW. THE FIRST PATIENT COMPLAINED OF POST OP EYE PAIN FOLLOWING A PAIN MANAGEMENT PROCEDURE AND THE SECOND PATIENT COMPLAINED THAT SHE FELT AS IF THERE WAS SOMETHING INSIDE HER EYE. THE FIRST PATIENT WAS REFERRED TO AN IN-HOUSE EYE SPECIALIST AND IT WAS DETERMINED THAT SHE HAD A MILD CORNEAL ABRASION. THE SECOND PATIENT'S EYE WAS FLUSHED AND FELT BETTER AFTER 24 HOURS. BOTH PATIENTS HAVE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1937 GENTLETOUCH PILLOW SUPPORT, PATIENT FWZ MIZUHO ORTHOPEDIC SYSTEMS, INC. 1937

    Patients

    Seq Age Sex Outcome Treatment
    1 Other