BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYDROCOLLATOR

    MDR report key: 288153 · Received July 28, 2000

    Report

    Report Number
    MW1019401
    Event Type
    Other
    Date Received
    July 28, 2000
    Date of Event
    July 21, 2000
    Report Date
    July 28, 2000
    Manufacturer
    CHATTANOOGA GROUP, INC.
    Product Code
    ITH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING COURSE OF TREATMENT, 13 MINS INTO 15 MIN SESSION, THE ROPE APPLYING STEADY PULL ON TRACTION BAR SUDDENLY DISLODGED OUT OF MACHINE, CREATING A SUDDEN RELEASE OF ALL TENSION AND PT SUSTAINED A SUDDEN JERK. ROPE WAS NOTED TO HAVE NOT BROKEN BUT HAD SOMEHOW UNWOUND IN INTERNAL MECHANISM AND SUDDENLY RELEASED DURING THIS TREATMENT SESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROCOLLATOR TX TRACTION UNIT ITH CHATTANOOGA GROUP, INC. TX-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other