BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASYSTAND STRAPSTAND

    MDR report key: 3144974 · Received May 31, 2013

    Report

    Report Number
    2183634-2013-00002
    Event Type
    Other
    Date Received
    May 31, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    ION
    PMA / PMN Number
    K885343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTIMATE MEDICAL CONTACTED THE UPHOLSTERY SUPPLIER AND HAD FABRIC COVERS MADE FOR THIS PARTICULAR FACILITY PER THEIR REQUEST.

    Description of Event or Problem · 1

    ON (B)(4) 2013 ALTIMATE MEDICAL RECEIVED A PHONE CALL FROM A MEDICAL EQUIPMENT DEALER REQUESTING ARM COVERS FOR THEIR EASYSTAND STRAPSTAND DUE TO A CLIENT GETTING A SKIN TEAR/CUT WHEN GOING FROM THE STANDING TO THE SITTING POSITION. TO OBTAIN MORE INFORMATION REGARDING HOW THIS OCCURRED, ALTIMATE CONTACTED THE FACILITY AND WAS INFORMED THAT THIS FACILITY HAS ELDERLY PATIENTS THAT ARE ON COUMADIN AND THAT THEIR SKIN IS VERY SENSITIVE AND CAN CUT VERY EASILY. BECAUSE OF THIS, THE FACILITY REQUESTED FABRIC COVERS TO COVER THE METAL ON THE ARMS OF THE EASYSTAND STRAPSTAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240267 EASYSTAND STRAPSTAND 890.5370 ION ALTIMATE MEDICAL, INC. STRAPSTAND NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other