BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMEGATRAC

    MDR report key: 2624001 · Received November 19, 2008

    Report

    Report Number
    3006654680-2008-00007
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 21, 2008
    Report Date
    November 19, 2008
    Manufacturer
    NEXT MOBILITY
    Product Code
    ITI
    PMA / PMN Number
    K013307
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS ORIGINALLY MFG BY THE TEFTEC CORP. NEXT MOBILITY HAS SINCE ACQUIRED THE ASSETS OF TEFTEC AND PROVIDES SERVICE AND SATISFIES THE WARRANTY CLAIMS OF THE LEGACY DEVICES PER AGREEMENT WITH TEFTEC. NEXT MOBILITY NOW MANUFACTURES AND MARKETS THE NEW PRODUCTION OF THE OMEGATRAC. NEXT MOBILITY CONTINUES TO ATTEMPT TO RETRIEVE THE DEVICE FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THE FATHER, ON BEHALF OF THE END USER, STATES THAT THE END USER TIPPED FORWARD OUT OF THE DEVICE. THE END USER STATES THAT HE DOES NOT USE RESTRAINTS WHEN OPERATING THE DEVICE. THE FATHER OF THE END USER STATES THAT HE BELIEVES THAT THE DEVICE BECOMES TOP-HEAVY WHEN HIS SON IS OPERATING THE DEVICE. THE FATHER STATES THE SON HAS TIPPED OUT OF THE DEVICE SEVERAL TIMES AND THE INCIDENT HAS NOT BEEN REPORTED UNTIL NOW. THE FATHER STATES THAT THE MOST RECENT INCIDENT CAME WHEN THE END USER WAS TRAVERSING A CURB IN THE FORWARD POSITION. THE END USER SOUGHT MEDICAL ATTENTION FOR OTHER UNRELATED MATTERS AND HAD X-RAYS COMPLETED. THE END USER REPORTS A BROKEN ANKLE AND A FRACTURED ANKLE. THE END USER ALSO REPORTS SCRAPES TO THE ARM AND OTHER AREAS OF THE BODY. THE END USER STATES THAT THE BACK CASTERS LIFT OFF THE GROUND WHEN HE COMES TO A STOP. THE END USER STATES THAT THERE WERE NO OTHER MALFUNCTIONS AND THE CHAIR OPERATES NORMALLY FOLLOWING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMEGATRAC WHEELCHAIR, POWERED ITI NEXT MOBILITY MODEL 11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention