BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASYSTAND 5000

    MDR report key: 1960297 · Received January 10, 2011

    Report

    Report Number
    2183634-2011-00001
    Event Type
    Other
    Date Received
    January 10, 2011
    Date of Event
    November 1, 2010
    Report Date
    January 5, 2011
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    IKX
    PMA / PMN Number
    K885343
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN (B)(6) MANAGER REVIEWED THE UNIT AT THE FACILITY, HE FOUND IT TO BE FUNCTIONING PROPERLY OTHER THAN THE FACT THAT A MODIFIED TABLE HAD BEEN BEING USED ON THE UNIT. IN ADDITION, (B)(6) MANAGER SPOKE WITH A MEMBER OF THE (B)(6) DEPARTMENT AT THIS FACILITY ON (B)(6) 2010, AND IT WAS STATED THAT THE (B)(6) DEPARTMENT DID NOT BELIEVE THE EASYSTAND WAS THE CAUSE FOR THE INJURY. AS STATED EARLIER THE CAUSE FOR THE ARM FRACTURE IN THIS PT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    RECEIVED AN E-MAIL FROM OUR (B)(6) MGR. THAT HE WAS ASKED TO COME TO A FACILITY TO REVIEW AN EASYSTAND THAT MAY HAVE CONTRIBUTED TO A FRACTURE OF AN INDIVIDUAL. HE VISITED THE FACILITY AND FOUND THAT THE FACILITY HAD MANUFACTURED THEIR OWN CUSTOM TABLE AND THIS TABLE WAS BEING USED WITH EASYSTAND 5000. HE TOOK PHOTOS OF THE UNIT AND THE MODIFIED TABLE DURING HIS VISIT. ON (B)(6) 2010, (B)(6) SPOKE WITH THE (B)(6) FOR PROGRAM COMPLIANCE AND RISK MANAGEMENT AT (B)(6). SHE STATED THAT SOMETIME IN (B)(6) 2010, SWELLING AND BRUISING WAS NOTED ON THE PATIENT'S ARM AND AFTER THIS BEING CHECKED OUT, IT WAS FOUND THE PT HAD A FRACTURE IN THEIR ARM. SHE ALSO STATED AN INVESTIGATION WAS COMPLETED BY THE FACILITY AND THAT THE FACILITY WAS UNABLE TO DETERMINE WHEN THE FRACTURE OCCURRED. THE INVESTIGATION NOTED THAT THE HEIGHT OF THE TABLE ON THE EASYSTAND MATCHED WHERE THE FRACTURE OCCURRED ON THE PATIENT'S ARM WHICH IS WHY IT WAS SUGGESTED THE EASYSTAND MAY HAVE CONTRIBUTED TO THE FRACTURE. THE FACILITY WAS UNABLE TO PROVIDE ME WITH A COPY OF THEIR INTERNAL INVESTIGATION FOR OUR RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYSTAND 5000 890.5370 IKX ALTIMATE MEDICAL, INC. 5000

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention