BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPRT SLEEP SURFACE

    MDR report key: 3182972 · Received June 21, 2013

    Report

    Report Number
    0001831750-2013-05685
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - MANUFACTURERS INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS AN INSPECTION WAS NOT ABLE TO BE PERFORMED FOR THIS ISSUE. THE CUSTOMER COULD NOT IDENTIFY THE MATTRESS OR MAKE IT AVAILABLE FOR EVALUATION BY A STRYKER TECHNICIAN. ISSUE RESOLVED BY VERIFYING THE CUSTOMER DID NOT NEED ANY FURTHER ACTION ON THIS ISSUE. MATTRESS NOT IDENTIFIED OR MADE AVAILABLE FOR EVALUATION BY A STRYKER TECHNICIAN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT THE PATIENT'S SKIN BROKE DOWN WHILE ON THE MATTRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT THE PATIENT'S SKIN BROKE DOWN WHILE ON THE MATTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283119 XPRT SLEEP SURFACE BED, PATIENT ROTATION, POWERED IKZ STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1