BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAUNDERS CERVICAL TRACTION

    MDR report key: 1812319 · Received August 10, 2010

    Report

    Report Number
    1022819-2010-00012
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 6, 2010
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED THAT SHE HAD A HERNIATED DISK AND WENT TO A REHABILITATION CLINIC AND WAS TREATED WITH A SAUNDERS CERVICAL. THE TWO BARS WERE ON HER JAW, NOT NECK, AND IT AFFECTED HER JAW. SHE WAS IN THE DEVICE FOR 7 MINUTES AND SHE STOPPED IT. AFTER THE TREATMENT WAS DISCONTINUED, SHE SAYS THAT THE SIDE OF HER JAW IS NOW OVERLAPPED ON THE RIGHT SIDE, HER BITE IS TERRIBLE AND HER HEARING IS DIMINISHED. IN AN EMAIL ON (B)(6) 2010, THE PATIENT ALSO STATED THAT SHE HAS BEEN DIAGNOSED WITH "RIGHT SIDE JAW DISLOCATION AND A CLOSED LOCK MY OPENING IS AT 7MM..., BUCCAL TRIGEMINAL NERVE DAMAGE POSSIBLY MORE NERVES DUE TO THE EXTENT OF THE NUMBNESS IN THE RIGHT SIDE OF FACE AND HEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAUNDERS CERVICAL TRACTION CERVICAL TRACTION CLINICAL IRS CHATTANOOGA GROUP 7040

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention