BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMEGATRAC

    MDR report key: 2191889 · Received March 6, 2008

    Report

    Report Number
    3003695985-2008-00002
    Event Type
    Other
    Date Received
    March 6, 2008
    Date of Event
    February 1, 2008
    Report Date
    March 6, 2008
    Manufacturer
    NEXT MOBILITY
    Product Code
    ITI
    PMA / PMN Number
    K013307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE INCIDENT DOES NOT ALLEGE SERIOUS BODILY INJURY AS DEFINED BY STATUTE. NEXT MOBILITY IS NOT AWARE IF MEDICAL INTERVENTION WAS SOUGHT OR REQUIRED TO PREVENT SERIOUS BODILY INJURY. EVALUATION: THE ALLEGED FAILED SUBCOMPONENT IS A POWER-ELEVATING LEGREST. THE USER STATES THAT THERE WAS ONLY PHYSICAL DAMAGE AND THE ELECTRONICS ARE INTACT. RESULTS: THE DEVICE WAS MODIFIED FOLLOWING THE REPORT OF THE BROKEN LEGREST DURING THE TIME THE COMPONENT WAS ON BACK ORDER. FURTHER INVESTIGATION AND INQUIRIES WITH THE DEALER CONCLUDE UNAUTHORIZED MODIFICATION CONTRIBUTED TO THE PRESSURE SORES REPORTED. THIS DEVICE WAS ORIGINALLY MANUFACTURED BY TEFTEC. NEXT MOBILITY HAS SINCE ACQUIRED THE ASSETS OF TEFTEC AND CONTINUES TO SUPPORT WARRANTY CLAIMS AND CUSTOMER SERVICE REQUESTS OF THE TEFTEC LEGACY DEVICES ALONG WITH NEW PRODUCTION OF THE OMEGATRAC. THE END USER COULD NOT BE CONTACTED REGARDING THE INCIDENT AND ALL INFORMATION WAS FURNISHED BY THE DEALER. NEXT MOBILITY HAS ATTEMPTED TO RETRIEVE THE BROKEN DEVICE FOR EVALUATION AND IT HAS NOT BEEN RETURNED FROM THE END USERS POSSESSION AS OF THE DATE OF THIS REPORT. NEXT MOBILITY CONTINUES TO ATTEMPT TO RETRIEVE THE BROKEN FOOTREST WITH COOPERATION FROM THE DEALER FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THE DEALER, ON BEHALF OF THE END USER, CALLED TO ORDER REPLACEMENT LEGREST COMPONENTS FOR THE DEVICE. PRIOR TO SHIPMENT OF THE BACK-ORDERED LEGRESTS, THE DEALER CALLED AND REPORTED THAT THE LEGREST WAS BROKEN AT THE KNEE AND THE END USER HAD REPORTED TO THE DEALER THAT HE HAD DEVELOPED PRESSURE SORES. THE DEALER REPORTED THAT THEY WERE AWARE THAT THE USER HAD ATTEMPTED AN UNAUTHORIZED MODIFICATION OF THE BROKEN LEGREST BY ATTACHING A BAKING SHEET TO SUPPORT THE LEG. THE DEALER STATES THAT THEY WERE UNAWARE OF THE EXTENT OF THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMEGATRAC WHEELCHAIR, POWERED ITI NEXT MOBILITY 12 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other