BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR EXPRESS MATTRESS

    MDR report key: 6118910 · Received November 21, 2016

    Report

    Report Number
    0001831750-2016-00371
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    September 30, 2016
    Report Date
    January 3, 2017
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS RESOLVED FOR THE CUSTOMER BY CONFIRMING THAT NOTHING FURTHER WAS NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FEEL OUT OF A NON-STRYKER BED THAT WAS USING A STRYKER AIR EXPRESS MATTRESS. NO MALFUNCTION WITH THE MATTRESS WAS REPORTED. HOWEVER, THE PATIENT EXPERIENCED A LACERATION TO THE FOREHEAD AND NOSE, A HEMATOMA OF THE FOREHEAD, AND A FRACTURED RIGHT NASAL. THE PATIENT WAS TREATED FOR THESE INJURIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FEEL OUT OF A NON-STRYKER BED THAT WAS USING A STRYKER AIR EXPRESS MATTRESS. NO MALFUNCTION WITH THE MATTRESS WAS REPORTED. HOWEVER, THE PATIENT EXPERIENCED A LACERATION TO THE FOREHEAD AND NOSE, A HEMATOMA OF THE FOREHEAD, AND A FRACTURED RIGHT NASAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770141 AIR EXPRESS MATTRESS MATTRESS, FLOTATION THERAPY, NON-POWERED IKY STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1