BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMFRTGL,W/BX,W/FB80X35X7,INTL

    MDR report key: 8361286 · Received February 22, 2019

    Report

    Report Number
    0001831750-2019-00272
    Event Type
    Injury
    Date Received
    February 22, 2019
    Date of Event
    February 11, 2019
    Report Date
    May 21, 2019
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT WITHIN A FEW HOURS, THERE WAS A DECUBITUS ULCER DEVELOPMENT ON THE HEEL AND ANKLE OF A PATIENT. THE PATIENT WAS ALLEGED TO BE ON THE SURFACE FOR 6 DAYS AND WAS TURNED TO APPROXIMATELY 12 POSITIONS WITHIN 24 HOURS. THE PATIENT WAS ALLEGED NOT TO HAVE ANY PRE-EXISTING CONDITIONS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY. THE PATIENT WAS GIVEN A SCORE OF 13 ON THE NORTON SCALE. IT WAS NOTED THAT A SCORE OF 25 AND LOWER INDICATES A PRESSURE ULCER RISK. THE PATIENT WAS DIAGNOSED WITH A DECUBITUS STAGE 1 ULCER SHOWING NON-IRRITABLE REDNESS OF THE SKIN AND WAS TREATED WITH MIPILEX BORDER (OVER THE COUNTER FOAM DRESSING) FOR SKIN PROTECTION. THERE WERE NO DEFECTS ALLEGED WITH THE MATTRESS. IT IS UNKNOWN IF THE PRODUCT MET SPECIFICATIONS AS THE PRODUCT WAS NOT EVALUATED BY A STRYKER REPRESENTATIVE. HOWEVER, WITH THE ALLEGED CONDITION THE PRODUCT WOULD MEET SPECIFICATIONS AS THERE WERE NO DEFECTS ALLEGED WITH THE PRODUCT. AFTER INVESTIGATION, THE CAUSE FOR THE STAGE 1 PRESSURE INJURY WAS FOUND TO NOT LIKELY BE RELATED TO A DEFECT WITH THE PRODUCT. THE PATIENT'S LOW NORTON SCORE MAY HAVE ATTRIBUTED TO THE DETERIORATION OF THE PATIENT'S SKIN. NO DEVICE PROBLEM ALLEGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A FEW HOURS, THERE WAS A DECUBITUS ULCER DEVELOPMENT ON THE HEEL AND ANKLE OF A PATIENT. FURTHER INFORMATION IS NOT AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A FEW HOURS, THERE WAS A DECUBITUS ULCER DEVELOPMENT ON THE HEEL AND ANKLE OF A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154923 COMFRTGL,W/BX,W/FB80X35X7,INTL MATTRESS, FLOTATION THERAPY, NON-POWERED IKY STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1