BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYSTAND EVOLV

    MDR report key: 2994753 · Received March 4, 2013

    Report

    Report Number
    2183634-2013-00001
    Event Type
    Malfunction
    Date Received
    March 4, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    INO
    PMA / PMN Number
    K062402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROPER REPLACEMENT PARTS FOR THE SEAT ASSEMBLY WERE SHIPPED TO THE REP AND RETURN AUTHORIZATION INFORMATION WAS SENT TO HAVE THE OTHER PARTS SHIPPED BACK TO ALTIMATE MEDICAL FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS OBTAINED WHEN THE EVALUATION IS COMPLETED, THEN A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 ALTIMATE MEDICAL RECEIVED A PHONE CALL FROM ONE OF THEIR INDEPENDENT REPRESENTATIVES STATING THAT HE HAD CUT HIS FINGER WHILE TRYING TO ADJUST THE SEAT DEPTH ON AN EASYSTAND EVOLV. THE REP HAD HIS FINGER CHECKED OUT AT HIS LOCAL CLINIC AND NO ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91515 EASYSTAND EVOLV 890.3110 INO ALTIMATE MEDICAL, INC. EVOL LARGE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other