BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-2100

    MDR report key: 2162054 · Received July 12, 2011

    Report

    Report Number
    3008729547-2011-00003
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    March 11, 2011
    Report Date
    July 12, 2011
    Manufacturer
    CRITIKON DE MEXICO S. DE R.L. DE C.V.
    Product Code
    IOL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PT IDENTIFIER, AGE AND WEIGHT HAVE NOT BEEN MADE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A T-2100 TREADMILL INCREASED SPEED ON ITS OWN RESULTING IN A PT FALL. THE PT EXPERIENCED KNEE ABRASIONS, A BROKEN TOE, AND HAND PAIN FOR WHICH A SPECIALIST WAS CONSULTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-2100 POWERED TREADMILL IOL CRITIKON DE MEXICO S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention