OtherITH
HYDROCOLLATOR
Received Jul 28, 2000 · Event occurred Jul 21, 2000
Report MW1019401 · MDR key 288153
Device
Generic name
Tx Traction Unit
Manufacturer
Chattanooga Group, Inc.Model number
TX-1Catalog number
*
Lot number
*
Product problems
- Collapse
- Dislodged
Patient
38 YR
- Other (for use when an appropriate patient code cannot be identified)
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
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.