BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRONEVIEW CUSHION INSERT

    MDR report key: 2581697 · Received April 24, 2012

    Report

    Report Number
    2921578-2012-00005
    Event Type
    Other
    Date Received
    April 24, 2012
    Report Date
    March 12, 2012
    Manufacturer
    DUPACO INC.
    Product Code
    CCX
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LABELING AND OF PT BLISTERS WITH THE DESIGNER DR. (B)(6) IT WAS DETERMINED THAT THE USER DID NOT ENSURE THE PT WHILE PRONE THE PT'S HEAD POSITION WAS NOT IN THE NEUTRAL POSITION. A NEUTRAL POSITION AND PT MONITORING CAN ENSURE ABRASIONS DO NOT OCCUR.

    Description of Event or Problem · 1

    DURING THE USE OF THE PRONEVIEW CUSHION INSERT, TWO PTS HAD SKIN ABRASIONS ON THEIR CHIN AND CHEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRONEVIEW CUSHION INSERT PILLOW CCX DUPACO INC. D28503CE

    Patients

    Seq Age Sex Outcome Treatment
    1