MalfunctionITH
CHATTANOOGA
Received Jun 27, 2016 · Event occurred Jun 6, 2016
Report 9616086-2016-00015 · MDR key 5751020
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE NOT RETURNED.
Description of Event or Problem
COMPLAINT RECEIVED THAT ALLEGES "PUT PATIENTS ON TRACTION FOR 20 LBS. WHILE BEING USED WITH THE PATIENTS, THE UNIT PULLED OVER 20 LBS, AS IF THE ROPE WAS BEING FULLY RETRACTED INTO THE MACHINE". QUESTIONNAIRE NOT RECEIVED FROM CLINICIAN AND/OR PATIENT. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION. NO INDICATION EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, PERMANENT IMPAIRMENT OR DEATH.