BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMA

    MDR report key: 751856 · Received August 15, 2006

    Report

    Report Number
    9614750-2006-00001
    Event Type
    Injury
    Date Received
    August 15, 2006
    Date of Event
    July 6, 2004
    Report Date
    August 14, 2006
    Manufacturer
    ITO CO., LTD.
    Product Code
    ITH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IS NOT POSSIBLE YET. INITIAL REPORT WAS RECEIVED FROM PATIENT'S ATTORNEY APPROXIMATELY TWO (2) YEARS AFTER THE CLAIMED ADVERSE EVENT. DISTRIBUTOR INITIALLY CONTACTED USER FACILITY, BUT WAS UNSUCCESSFUL IN EITHER CONFIRMING EVENT OR GATHERING FURTHER DETAILS REGARDING EVENT. U.S. AGENT FOR MANUFACTURER IS NOW DIRECTLY SEEKING ADDITIONAL INFORMATION FROM USER FACILITY REGARDING USE CONDITIONS, PATIENT OUTCOME, AND LOCATION/CONDITION/AVAILABILITY OF DEVICE FOR EVALUATION. REPORT UPDATE(S) SHALL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    FROM A LETTER DATED 06/09/06 RECEIVED FROM AN ATTORNEY REPRESENTING THE PATIENT, IT IS CLAIMED THAT THE PATIENT "WAS ON TRACTION EQUIPMENT" AT A USER FACILITY IN 2004, WHEN THE DEVICE "MALFUNCTIONED, CAUSING SERIOUS INJURY TO BOTH OF [PATIENT]'S SHOULDERS." LETTER WAS SENT TO MANUFACTURER AND DISTRIBUTOR, BUT WITH NO ADDITIONAL INFORMATION REGARDING PATIENT CONDITION, USE CONDITIONS, OR OTHER RELEVANT DETAILS. IT IS YET UNKNOWN WHETHER CLAIMED INJURY WAS TEMPORARY OR IS PERMANENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMA EQUIPMENT, TRACTION, POWERED (ITH) ITH ITO CO., LTD. TM-300 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Disability