BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOWBACK CHAIR W/ARMS 18"

    MDR report key: 2421662 · Received January 11, 2012

    Report

    Report Number
    1831750-2012-00337
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    December 13, 2011
    Report Date
    December 14, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    KMN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BACK SUPPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, WHEN THE DRIVER PULLED THE CHAIR OUT OF ITS BOX HE REPORTS THAT THE BACK SUPPORT ON THE WOOD FRAME WAS SPLIT IN HALF. IT WAS REPORTED THERE WERE EXPOSED SHARP EDGES. THERE WAS NO REPORTED PT INVOLVEMENT OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOWBACK CHAIR W/ARMS 18" CHAIR AND TABLE, MEDICAL KMN STRYKER MEDICAL 35000000015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1