BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYSTAND STRAPSTAND

    MDR report key: 1977712 · Received January 28, 2011

    Report

    Report Number
    2183634-2011-00002
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 7, 2011
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    ION
    PMA / PMN Number
    K885343
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CONVERSATION WITH THE CLINICAL NURSE SPECIALIST THE EASYSTAND STRAPSTAND IS FUNCTIONING PROPERLY AS IT SHOULD. THE REASON THEY CONTACTED ALTIMATE IS TO REQUEST A DIFFERENT TYPE OF SLING, THAT USES A TWO STRAP WEB DESIGN (SIMILAR TO A STRAP USED ON A COMPETITOR'S STANDING FRAME). IN ADDITION, THE PT HAD THIS ULCER PRIOR TO USING THE STANDING FRAME. THE ULCER HAD HEALED OVER BUT REPRESENTED ITSELF AFTER THE STRAP SLID UP AND OVER HIS BOTTOM.

    Description of Event or Problem · 1

    SPOKE WITH A CLINICAL NURSE SPECIALIST FROM THE (B)(6) CLINIC REGARDING A PT THAT USES AN EASYSTAND STRAPSTAND IN HIS HOME. SHE STATED THAT THIS USER HAS VERY HIGH TONE AND IS SPASTIC WHICH RESULTS IN HIM MOVING AROUND WHILE HE IS IN HIS STRAPSTAND. DUE TO THIS SHE STATED THAT THE STRAP SLID UP AND OVER HIS BOTTOM, RESULTING IN OPENING A CLOSED ULCER THAT HAD PREVIOUSLY HEALED OVER. THE ULCER WAS BANDAGED BY A NURSE PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYSTAND STRAPSTAND 890.5370 ION ALTIMATE MEDICAL, INC. 2000

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention