BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPRT W/O PENDANT W/DARTEX

    MDR report key: 2964635 · Received February 15, 2013

    Report

    Report Number
    0001831750-2013-01229
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 22, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MATTRESS MAY NOT BE AVAILABLE FOR EVALUATION. RESULTS: ALLEGED FLUID INGRESS INTO MATTRESS.CONCLUSION: IF MATTRESS IS EVALUATED, A SUPPLEMENTAL WILL BE SUBMITTED IF APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THERE WAS FLUID INGRESS IN THE XPRT MATTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66326 XPRT W/O PENDANT W/DARTEX MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1