BEUDAMED
    FDA Adverse Event Other Summary report: N

    PILLOW

    MDR report key: 1908948 · Received November 15, 2010

    Report

    Report Number
    2921578-2010-00015
    Event Type
    Other
    Date Received
    November 15, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 12, 2010
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    FWZ
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENT WAS REVIEWED WITH HOSPITAL AND WITH PT, WE ARE UNSURE AS THE CAUSE OF THE EVENT, AS THE PRODUCT IS MADE FROM POLYURETHANE AND THERE ARE CONFLICTING NOTIFICATIONS CONCERNING THE RASH AS TRIANGULAR IN SHAPE AND THAT THE OXYGEN MASK IS LATEX FREE. THE PT HAS BEEN TREATED FOR THE REACTION AND NO OTHER INCIDENTS HAVE BEEN ISSUED BY THIS HOSP AND/OR ANY OTHER HOSPITALS THAT USE THE PILLOW ((B)(4) DISTRIBUTION). REFERENCE REPORT # 2921578-2010-00015 FOR DEVICE 2.

    Description of Event or Problem · 1

    PT ENDURED RASH ON FACE FOLLOWING SPINAL SURGERY. RASH CAUSED BUBBLING OF SKIN UNDER EYES AND PRIMARY CARE DOCTOR STATED APPEARED TO BE AN ALLERGIC REACTION TO LATEX AND WAS IN THE SHAPE OF AN OXYGEN MASK; HOWEVER, ANESTHESIOLOGIST STATED THE RASH WAS CAUSED BY THE MIZUHO OSI PILLOW. PT WAS INFORMED PILLOW WAS MADE FROM POLYURETHANE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other