BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 2421288 · Received January 6, 2012

    Report

    Report Number
    2431314-2011-00002
    Event Type
    Other
    Date Received
    January 6, 2012
    Manufacturer
    BIODEX MEDICAL SYSTEMS, INC.
    Product Code
    UNK
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    WE TALKED TO THE FACILITY AND THEY SAID THE THERAPIST DID NOT SET IT UP CORRECTLY. THE MACHINE IS FUNCTIONING CORRECTLY. THEY TRIED REPRODUCING THE PROBLEM WITH A CORRECT RANGE OF MOTION SET UP AND IT FUNCTIONS CORRECTLY. THERE IS NO PROBLEM WITH THE UNIT. PLEASE NOTE: THE PATIENT WAS NOT INJURED.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE UNK BIODEX MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1