BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP .84"GORE W/O FB & BOX PKG

    MDR report key: 2419911 · Received December 14, 2011

    Report

    Report Number
    1831750-2011-13366
    Event Type
    Malfunction
    Date Received
    December 14, 2011
    Date of Event
    November 14, 2011
    Report Date
    November 15, 2011
    Manufacturer
    FLEXTRONICS EMS CANADA
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PTS ALLEGEDLY DEVELOPED PRESSURE ULCERS WHILE ON THE IMPRESSION SURFACES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMP .84"GORE W/O FB & BOX PKG MATTRESS FNM FLEXTRONICS EMS CANADA 2981000003 NA

    Patients

    Seq Age Sex Outcome Treatment
    1