BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRONE VIEW CUSHION INSERT

    MDR report key: 2892802 · Received December 26, 2012

    Report

    Report Number
    MW5028384
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    September 11, 2012
    Report Date
    December 26, 2012
    Manufacturer
    MIZUHO OSI
    Product Code
    KME
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT FOUND TO HAVE A SKIN WOUND AFTER USE OF THE PRONE VIEW PILLOW DURING PROLONGED SURGERY APPROX 9 1/2 HOURS. THE WOUND WAS NOT EVIDENT UNTIL THE DAY AFTER SURGERY. REASON FOR USE: PRONE POSITION DURING SURGERY FOR LUMBAR FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRONE VIEW CUSHION INSERT PRONE VIEW CUSHION INSERT KME MIZUHO OSI D28503CE
    2 VIEW PILLOW VIEW PILLOW KME MIZUHO OSI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other