BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3041410 · Received April 8, 2013

    Report

    Report Number
    0002090040-2013-00007
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
    Product Code
    JOW
    PMA / PMN Number
    K090308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. PACKAGING INFORMATION WAS NOT PROVIDED EITHER SO MANUFACTURE DATE AND LOT NUMBER WERE NOT AVAILABLE. THE INSTRUCTIONS FOR USE (IFU) FOR RCG10 CALF GARMENTS STATES: "GARMENTS SHOULD BE REMOVED REGULARLY TO INSPECT THE SKIN." "GARMENTS SHOULD BE REMOVED IMMEDIATELY IF THE PATIENT EXPERIENCES ANY UNEXPLAINED SENSATIONS, NUMBNESS, OR PAIN." THE RESTEP SYSTEM SHOULD NOT BE USED IN THE FOLLOWING CONDITIONS: "LOCAL SKIN OR TISSUE CONDITIONS IN WHICH THE GARMENTS WOULD INTERFERE." A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION. HOWEVER, IT IS POSSIBLE THAT THE MATTRESS, WHEELCHAIR/CUSHION, AND TURNING TECHNIQUES COULD HAVE ATTRIBUTED OR AIDED IN THE REPORTED ISSUE AS WELL. IF THE ULCER SEEMS TO BE CAUSED BY FRICTION, A PROTECTIVE TRANSPARENT DRESSING SUCH AS OP-SITE OR TEGADERM MAY HELP PROTECT THE AREA BY ALLOWING THE SKIN TO SLIDE EASILY. THIS IS THE FIRST REPORT OF THIS TYPE THAT SSS HAS RECEIVED. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "A RESTEP DVT SLEEVE CAUSED A PRESSURE ULCER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143678 NA JOW JOW STRYKER SUSTAINABILITY SOLUTIONS PHOENIX RCG10 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1